Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509662689795 Date of Registration: 10/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MK8527-010: MK‑8527 as HIV-1 PrEP in Women
Official scientific title A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK‑8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
Brief summary describing the background and objectives of the trial Researchers are looking for new medicines to prevent HIV-1 infection. In this study, MK-8527 is being evaluated as a potential once-monthly oral prevention option for HIV-1 in 4,580 sexually active women aged 16 to 30 in Kenya, South Africa, and Uganda. The goals of the study are to learn: If taking MK-8527 once a month works to prevent HIV-1 as well as or better than a standard (PrEP) taken once a day About the safety of MK-8527 and if people tolerate it
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EXPrESSIVE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 27/09/2025
Actual trial start date
Anticipated date of last follow up 30/04/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 4580
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL www.msd.co.za
Secondary Ids Issuing authority/Trial register
MK8527 010 MSD Pty Ltd.
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MK 8527 11 mg once a month 24 months MK-8527 is a novel deoxyadenosine analog with potent antiviral activity being developed for the prevention of HIV-1 infection, with future considerations for treatment. 1145
Control Group FTC TDF 200/245 mg 24 months Emtricitabine/Tenofovir Disoproxil is a combination antiretroviral medication used for the treatment and prevention of HIV-1 infection. Each film coated tablet contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate. 1145 Active-Treatment of Control Group
Experimental Group Placebo to FTC TDF 0 mg 24 months A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect. 1145
Control Group Placebo to MK8527 0mg 24 months A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect. 1145 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. 2.Has been sexually active (more than 2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months). 3.Was assigned female sex at birth and is cisgender. 4.Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent, as applicable. 5.Weighs more than 35 kg at enrollment. 6.A participant assigned female sex at birth is eligible to participate if not breast/chestfeeding. 7.A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test (urine or serum), as required by local regulations, has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. 8.The participant (or participant’s legally acceptable representative) has provided documented informed consent, and the participant has provided documented assent, when applicable, for the study. 9.Has no plans to travel or relocate away from the site that would interfere with attending monthly on-site visits for the duration of the study. 10.Is currently using an ENG-releasing implant (i.e., Nexplanon or Implanon NXT) or injectable-MPA or injectable-NET-EN or is willing to begin use at the Screening Visit. 1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator. 2. Has evidence of acute or chronic hepatitis B infection (HBsAg positive). 3. Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. 4. Has a history or current evidence of any condition (e.g., active tuberculosis infection or hepatic cirrhosis), therapy, laboratory abnormality or other circumstance (including substance or alcohol use disorder) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to enroll. 5. Has taken cabotegravir, lenacapavir, or any other longacting HIV prevention product at any time (past or current use). 6. Is currently receiving or is anticipated to require any prohibited therapies outlined in Section 6.5 from 30 days prior to Day 1 through the study duration (i.e., up to 56 ±5 days following the last dose of blinded monthly study intervention). 7. Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1. 8. Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device within 30 days prior to Day 1 through the duration of the study. 9. Has exclusionary laboratory values within 45 days prior to Day 1. 10. Is expecting to donate eggs at any time during the study. 11. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 30 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/06/2025 UNIVERSITY OF KWAZULU NATAL BIOMEDICAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Westville Campus Govan Mbeki Building Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 11/07/2025 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton Manor 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 18/06/2025 UCT HREC University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/07/2025 SAMRC The South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/06/2025 Wits HREC University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
31 Princess Wales Terrace Johannesburg 2041 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 23/07/2025 Uganda Virus Research Institute Research and Ethics Committee UVRI REC
Ethics Committee Address
Street address City Postal code Country
Plot No. 51 to 59 Nakiwogo Road P.O.BOX 49 Entebbe 30006 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 23/07/2025 UNCST Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Ntinda Kampala 00256 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2025 KEMRI SERU Kenya Medical Research Institute Site 0002
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, House Number 8, KEMRI Headquarters Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2025 KEMRI SERU Kenya Medical Research Institute Site 0003
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, House Number 8, KEMRI Headquarters Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2025 KEMRI SERU Kenya Medical Research Institute Site 0006
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, House Number 8, KEMRI Headquarters Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/08/2025 KEMRI SERU Kenya Medical Research Institute Site 0007
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, House Number 8, KEMRI Headquarters Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adjudicated HIV-1 infection End of Trial
Secondary Outcome There are no secondary outcome for this study Not applicable for this study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wits RHI Ward 21 Clinical Research Site 22 Esselen Street Johannesburg 2001 South Africa
DTHF Masiphumelele Clinical Research Site Guinea Fowl Road Cape Town 7975 South Africa
Desmond Tutu Health Foundation Philippi Village Cwangco Cresent Cape Town 7781 South Africa
Vuka Research Clinic 8 Mzala Street Khayelitsha 7784 South Africa
SA Medical Research Council Chatsworth Clinical Research Site 361 RK Khan Circle Chatsworth 4092 South Africa
Wits Maternal Adolescent and Child Health Research Unit WMRU 430 Peter Mokaba Ridge Durban 4001 South Africa
Qhakaza Mbokodo Research Clinic 15 Parklane Ladysmith 3370 South Africa
CAPRISA Vulindlela Research Site Road P402 Ward 9 Msunduzi Municipality Pietermaritzburg 3231 South Africa
CAPRISA eThekwini Clinical Research Site 3 University Avenue Greyville Berea Durban 4001 South Africa
FPD Ndevana Community Research Site 1270 Zintenteni Ndevana 5660 South Africa
Setshaba Research Centre 2088 Block H Soshanguve 0152 South Africa
Perinatal HIV Research Unit PHRU Chris Hani Road Diepkloof Soweto Johnnesburg 1864 South Africa
Madibeng Centre for Research 36 and 40 Pienaar Street Brits 0250 South Africa
SA Medical Research Council Bothas Hill Clinical Research Site 1 Zulu Reserve Road Botha s Hill Valley Trust Durban 3660 South Africa
SA Medical Research Council Verulam Clinical Research Site 31 to 33 Wick Street Verulam 4340 South Africa
SA Medical Research Council Phoenix Clinical Research Site 66 Pandora Street Starwood Phoenix 4068 South Africa
Synergy Biomed Research 247 Oxford Street East London 5241 South Africa
JOSHA Research 28 Burger Street Bloemfontein 9303 South Africa
Umlazi Clinical Research Site Prince Msheyeni Memorial Hospital Philasande PMTCT Clinic 1358 Mangosuthu Highway Umlazi Durban 4089 South Africa
Helen Joseph Hospital Clinical HIV Research Unit Perth Road Johannesburg 2092 South Africa
Africa Health Research Institute AHRI Mtubatuba AHRI CTU Somkhele Via R618 to Hlabisa Somkhele Mtubatuba 3935 South Africa
Kenya Medical Research Institute KEMRI Partners in Health Research and Development PHRD Section 9, OAU Road Thika Town 00202 Kenya
Kenya Medical Research Institute KEMRI Center for Microbiology Research CMR RCTP CIS Building, Lumumba Sub-County Hospital, Ondiek Road Kisumu 40100 Kenya
Kargeno Research and Policy Hub Karume Road, Jairo Street Junction Kisumu 40123 Kenya
UW KNH Rachuonyo County Hospital Clinical Trial Centre Rachuonyo County Referral Hospital Grounds in Oyugis town, off Oyugis Kendu Bay Road Oyugis 40222 Kenya
MUJHU MITYANA Mityana General Hospital Kikumbi Katakara Road Kampala 256 Uganda
MUJHU KAMPALA Upper Mulago Hill Road Kampala, Uganda. P. O. Box 23491 Kampala 256 Uganda
Infectious Diseases Institute IDI Kalangala Kalangala Health Center IV, Kalangala Main Street Kampala 256 Uganda
MRC UVRI and LSHTM Uganda Research Unit Plot 2 to 5 Ntikko Road Masaka 256 Uganda
Uganda Virus Research Institute International AIDS Vaccine Initiative UVRI IAVI Plot 51 to 59 Nakiwogo Road P.O.BOX 49 Entebbe 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
ICRC International Clinical Research Center University of Washington 325 Ninth Avenue Seattle 98104 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MSD Pty Ltd 117 16th Road Halfway House 1685 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Sue Bailey sue.bailey@msd.com +27116553307 117 16th Road
City Postal code Country Position/Affiliation
Halfway House 1685 South Africa Clinical Research Director Sub Saharan Africa
Role Name Email Phone Street address
Scientific Enquiries Linda Gail Bekker Linda-Gail.Bekker@hiv-research.org.za +27216506966 Main Road
City Postal code Country Position/Affiliation
Observatory 7925 South Africa University of Cape Town and National Principal Investigator
Role Name Email Phone Street address
Principal Investigator Sinead Delany Moretlwe sdelany@wrhi.ac.za +27113585300 22 Esselen Street
City Postal code Country Position/Affiliation
Hillbrow 2001 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Katherine Gill katherine.gill@hiv-research.org.za +27217853121 Guinea Fowl Road
City Postal code Country Position/Affiliation
Sunnydale 7975 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Philipa MacDonald pippa.macdonald@hiv-research.org.za +27216501073 Cwangco Crescent
City Postal code Country Position/Affiliation
Philippi 7781 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Amy Ward amy.ward@uct.ac.za +27216501551 8 Mzala Street
City Postal code Country Position/Affiliation
Khayalitsha 7784 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Logashvari Naidoo logashvari.naidoo@mrc.ac.za +27314014150 361 RK Khan Circle
City Postal code Country Position/Affiliation
Chatsworth 4092 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Manjeetha Jaggernath mjaggernath@mru.ac.za +27310011921 40 Dr AB Xuma Street
City Postal code Country Position/Affiliation
Durban 4001 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Nicole Gracie nicolegracie10@gmail.com +27366312372 15 Park Lane
City Postal code Country Position/Affiliation
Ladysmith 3370 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Disebo Potloane disebo.potloane@cagrisa.org +27316550687 Primary Health Care ClinicRoad P402
City Postal code Country Position/Affiliation
Pietermaritzburg 3231 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Ishana Harkoo ishana.harkoo@caprisa.org +27316550717 3 University Avenue
City Postal code Country Position/Affiliation
Berea 4001 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Joanne Batting joanne@foundation.co.za +27662761649 1207 Zintenteni
City Postal code Country Position/Affiliation
Ndevana 5660 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Zinhle Zwane zzwane@setshaba.org.za +27127992422 2088 Block H
City Postal code Country Position/Affiliation
Soshanguve 0152 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Ravindre Panchia panchiar@phru.co.za +27119899711 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto 1864 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Cheryl Louw clouw@cvmdibengresearch.co.za +27122521140 36 and 40 Pienaar Street
City Postal code Country Position/Affiliation
Brits 0250 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Elizabeth Spooner Elizabeth.Spooner@mrc.ac.za +27317771585 1 Zulu Road
City Postal code Country Position/Affiliation
Valley Trust 3660 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Nishanta Singh nishanta.singh@mrc.ac.za +27325334145 31 to 33 Wick Street
City Postal code Country Position/Affiliation
Verulam 4340 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Saresha Pillay saresha.pillay@mrc.ac.za +27315003536 66 Pandora Street
City Postal code Country Position/Affiliation
Phoenix 4061 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Nkosilathi Dlodlo drnkosilathi@sbri.org.za +27437222306 280 Oxford Road
City Postal code Country Position/Affiliation
East London 5241 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Megeshinee Naidoo naidoom6@ukzn.ac.za +27312601982 1358 Mangosuthu Highway
City Postal code Country Position/Affiliation
Umlazi 4066 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Mohammed Rassool mrassool@witshealth.co.za +27112768800 Perth Road
City Postal code Country Position/Affiliation
Westdene 2092 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Ngudu Behuhuma ngundu.behuhuma@ahri.org +27352510929 Via R618 to Hlabisa
City Postal code Country Position/Affiliation
Somkhele Mtubatuba 3935 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu +254733629665 Section 9, OAU Road, Thika Town
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukusi@rctp.or.ke +254722205901 CIS Building Lumumba Sub County Hospital, Ondiek Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Coordinating Principal Investigator
Role Name Email Phone Street address
Principal Investigator Maricianah Onono monono@kemri.go.ke +254732390992 Karume Road, Jairo Street Junction
City Postal code Country Position/Affiliation
Kisumu 40123 Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Irene Inwani iinwani@yahoo.com +254722608483 Rachuonyo County Referral Hospital Grounds in Oyugis Town, off Oyugis Kendu Bay Road
City Postal code Country Position/Affiliation
Oyugis 40222 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sue Bailey sue.bailey@msd.com +27116553307 117 16th Road
City Postal code Country Position/Affiliation
Halfway House 1685 South Africa Clinical Research Director Sub Saharan Africa
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Bukusi ebukusi@rctp.or.ke +254722205901 CIS Building, Lumumba Sub County Hospital, Ondiek Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Coordinating Principal Investigator
Role Name Email Phone Street address
Principal Investigator Flavia Kiweewa fmatovu@mujhu.org +256760334881 Mityana General Hospital Kikumbi Katakara Road
City Postal code Country Position/Affiliation
Mityana 00256 Uganda Coordinating Principal Investigator
Role Name Email Phone Street address
Principal Investigator Brenda Mirembe bgati@mujhu.org +256772881922 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 10216 Uganda Principal Investigator
Role Name Email Phone Street address
Principal Investigator Andrew Mujugira amujugira@idi.co.ug +256754173225 Kalangala Main Street
City Postal code Country Position/Affiliation
Kalangala District 30060 Uganda Principal Investigator
Role Name Email Phone Street address
Principal Investigator Eugene Ruzagira Eugene.Ruzagira@mrcuganda.org +256701030782 Plot 2 to 5 Ntikko Road
City Postal code Country Position/Affiliation
Masaka 00256 Uganda Principal Investigator
Role Name Email Phone Street address
Principal Investigator Juliet Mpendo jmpendo@iavi.or.ug +256772722381 Plot 51 to 59, Nakiwogo Road
City Postal code Country Position/Affiliation
Entebbe 30006 Uganda Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sue Bailey sue.bailey@msd.com +27116553307 117 16th Road
City Postal code Country Position/Affiliation
Halfway House 1685 South Africa Clinical Research Director Sub Saharan Africa
Role Name Email Phone Street address
Scientific Enquiries Flavia Kiweewa fmatovu@mujhu.org +256760334881 Mityana General Hospital, Kikumbi Katakara Road
City Postal code Country Position/Affiliation
Mityana 00256 Uganda Coordinating National Principal Investigator Uganda
Role Name Email Phone Street address
Principal Investigator Enid Kabugho ekabugho@mujhu.org 000256772516513 Upper Mulago Hill Road Kawempe Division P.O.Box 23491
City Postal code Country Position/Affiliation
Kampala 10291 Uganda Coordinating Investigator
Role Name Email Phone Street address
Principal Investigator Timothy Muwonge tmuwonge@idi.co.ug 256752811000 Kalangala Health Center IV Kalangala Main Street Kalangala District
City Postal code Country Position/Affiliation
Kampala Uganda Coordinating Investigator
Role Name Email Phone Street address
Principal Investigator Sylvia Kusemerewa sylvia.kusemererwa@mrcuganda.org +256485660468 Plot 2-5 Ntikko Road PO. Box 1603
City Postal code Country Position/Affiliation
Masaka 256 Uganda Coordinating Investigator
Role Name Email Phone Street address
Principal Investigator Annet Nanvubya ananvubya@iavi.or.ug +256772722377 Plot 51-59, Nakiwogo Road PO Box 49
City Postal code Country Position/Affiliation
Entebe 256 Uganda Coordinating Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes MSD is fully committed to supporting the EFPIA and PhRMA guiding principles on data sharing, including the principle of providing qualified scientific researchers access to anonymized participant-level data and full clinical study reports (CSRs) from MSD’s clinical trials to conduct legitimate scientific research. We are also fully participating in the Institutes of Medicine (IOM) global effort to develop principles for responsible sharing of clinical trial data. Scope of Data: MSD will provide access to participant-level data and CSRs from clinical trials performed by MSD for which results are posted on the clinicaltrials.gov registry (dating back to September 2007) for products or indications that have been approved by regulators in the US and EU. In general, data will be made available for request approximately 18 months after clinical trial completion. Data from phase I trials in healthy volunteers and consumer health care studies are out of scope for this procedure. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol From study start until end of retention period as per MSD policy period which is aligned with ICH-GCP IPD will be provided for: 1. GCP Inspections 2. Market approval audits 3. Ethics Committe Inspections 4. Other inspections No other data will be shared.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.msd.co.za No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 26/08/2025 Updated to add background about the study. MK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development for preventing HIV-1 infection, demonstrating potent antiretroviral activity. It is converted intracellularly to its active triphosphate form, MK-8527-TP, which specifically inhibits HIV-1 reverse transcriptase (RT) with an in vitro IC50of 0.21 nM, significantly more potent than existing nucleoside/nucleotide analogs like AZT and TDF. Despite the availability of prevention strategies, there is a pressing need for additional methods to reduce HIV acquisition. Pre-exposure prophylaxis (PrEP) has been recognized as an effective biomedical intervention for HIV prevention since its recommendation by the World Health Organization (WHO) in 2015 for individuals at substantial risk of infection. Current PrEP options, such as TRUVADA™ (FTC/TDF) and DESCOVY™(FTC/TAF), require daily oral administration, which has been shown to be effective but is often hindered by suboptimal adherence among high-risk populations. To address these adherence challenges, long-acting injectable PrEP options, such as APRETUDE™ (long-acting injectable cabotegravir), have been developed and approved, demonstrating superior efficacy compared to daily oral PrEP. However, access and implementation challenges limit its availability, and some potential users prefer oral formulations. In this context, long-acting oral agents, like MK-8527, present a promising alternative. MK-8527 has high potency and a long half-life, with its active form (MK-8527-TP) exhibiting an intracellular half-life of approximately 94 to 291 hours. The investigation of a once-monthly (qm) dosing regimen for MK-8527 aims to alleviate the burden of daily adherence and frequent clinic visits for injections, while maintaining high effectiveness in preventing HIV-1acquisition. Pre-exposure prophylaxis is a proven biomedical intervention for the prevention of HIV infection HIV negative individuals at risk for HIV infection.Current PrEP options,such as FTC/TDF,require daily oral administration,which has been shown to be effective but is often hindered by suboptimal adherence among high-risk populations.To address adherence challenges,long-acting injectable PrEP options,such as cabotegravir and lenacapavir,have been developed and approved in some countries,demonstrating superior efficacy compared to daily oral PrEP.However,access and implementation challenges limit its availability,and some potential users prefer oral formulations.Long-acting agents,such as a monthly pill,have the potential to reduce the risk of HIV-1 acquisition without relying on adherence to a daily regimen or clinic visits for injections.MK8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development for preventing HIV-1 infection,demonstrating potent antiretroviral activity.It is converted intracellularly to its active triphosphate form,MK-8527-TP,which specifically inhibits HIV-1 reverse transcriptase (RT) with an in vitro IC50of 0.21 nM, significantly more potent than existing nucleoside/nucleotide analogs like AZT and TDF.Despite the availability of prevention strategies, there is a pressing need for additional methods to reduce HIV acquisition.Pre-exposure prophylaxis has been recognized as an effective biomedical intervention for HIV prevention since its recommendation by the World Health Organization in 2015 for individuals at substantial risk of infection.MK8527 has high potency and a long half-life,with its active form (MK8527-TP) exhibiting an intracellular half-life of approximately 94 to 291 hours.The investigation of a once-monthly (qm) dosing regimen for MK8527 aims to alleviate the burden of daily adherence and frequent clinic visits for injections,while maintaining high effectiveness in preventing HIV-1 acqusition.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 02/09/2025 Update to correct the background and objectives of this trial. Pre-exposure prophylaxis is a proven biomedical intervention for the prevention of HIV infection HIV negative individuals at risk for HIV infection.Current PrEP options,such as FTC/TDF,require daily oral administration,which has been shown to be effective but is often hindered by suboptimal adherence among high-risk populations.To address adherence challenges,long-acting injectable PrEP options,such as cabotegravir and lenacapavir,have been developed and approved in some countries,demonstrating superior efficacy compared to daily oral PrEP.However,access and implementation challenges limit its availability,and some potential users prefer oral formulations.Long-acting agents,such as a monthly pill,have the potential to reduce the risk of HIV-1 acquisition without relying on adherence to a daily regimen or clinic visits for injections.MK8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development for preventing HIV-1 infection,demonstrating potent antiretroviral activity.It is converted intracellularly to its active triphosphate form,MK-8527-TP,which specifically inhibits HIV-1 reverse transcriptase (RT) with an in vitro IC50of 0.21 nM, significantly more potent than existing nucleoside/nucleotide analogs like AZT and TDF.Despite the availability of prevention strategies, there is a pressing need for additional methods to reduce HIV acquisition.Pre-exposure prophylaxis has been recognized as an effective biomedical intervention for HIV prevention since its recommendation by the World Health Organization in 2015 for individuals at substantial risk of infection.MK8527 has high potency and a long half-life,with its active form (MK8527-TP) exhibiting an intracellular half-life of approximately 94 to 291 hours.The investigation of a once-monthly (qm) dosing regimen for MK8527 aims to alleviate the burden of daily adherence and frequent clinic visits for injections,while maintaining high effectiveness in preventing HIV-1 acqusition. Researchers are looking for new medicines to prevent HIV-1 infection. In this study, MK-8527 is being evaluated as a potential once-monthly oral prevention option for HIV-1 in 4,580 sexually active women aged 16 to 30 in Kenya, South Africa, and Uganda. The goals of the study are to learn: If taking MK-8527 once a month works to prevent HIV-1 as well as or better than a standard (PrEP) taken once a day About the safety of MK-8527 and if people tolerate it
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 22/08/2025 Added study acronym. Not Applicable EXPrESSIVE
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 03/09/2025 The trial start date has been adjusted for correctness. 01 Sep 2025 27 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 03/09/2025 Updated to correct the number of participants. 3500 4580
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 22/08/2025 Updated to add each criterion on in single line. 1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. 2. Has been sexually active (more than 2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months). 3. Was assigned female sex at birth and is cisgender. 4. Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent, as applicable. 5. Weighs more than 35 kg at enrollment. 6. A participant assigned female sex at birth is eligible to participate if not breast/chestfeeding. 7. A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test (urine or serum), as required by local regulations, has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. 8. The participant (or participant’s legally acceptable representative) has provided documented informed consent, and the participant has provided documented assent, when applicable, for the study. 9. Has no plans to travel or relocate away from the site that would interfere with attending monthly on-site visits for the duration of the study. 10. Is currently using an ENG-releasing implant (i.e., Nexplanon or Implanon NXT) or injectable-MPA or injectable-NET-EN or is willing to begin use at the Screening Visit. 1.Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results during screening. 2.Has been sexually active (more than 2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months). 3.Was assigned female sex at birth and is cisgender. 4.Aged from 16 years to 30 years of age inclusive, at the time of providing the informed consent or assent, as applicable. 5.Weighs more than 35 kg at enrollment. 6.A participant assigned female sex at birth is eligible to participate if not breast/chestfeeding. 7.A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test (urine or serum), as required by local regulations, has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. 8.The participant (or participant’s legally acceptable representative) has provided documented informed consent, and the participant has provided documented assent, when applicable, for the study. 9.Has no plans to travel or relocate away from the site that would interfere with attending monthly on-site visits for the duration of the study. 10.Is currently using an ENG-releasing implant (i.e., Nexplanon or Implanon NXT) or injectable-MPA or injectable-NET-EN or is willing to begin use at the Screening Visit.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 28/08/2025 Update to include Adult Age Group Adolescent: 13 Year-18 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/08/2025 Updated to align with total number of participants number. Experimental Group, MK 8527, 11 mg once a month, 24 months, MK-8527 is a novel deoxyadenosine analog with potent antiviral activity being developed for the prevention of HIV-1 infection, with future considerations for treatment., 1166,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/09/2025 Updated the group size for the Intervention Arm Type. Experimental Group, MK 8527, 11 mg once a month, 24 months, MK-8527 is a novel deoxyadenosine analog with potent antiviral activity being developed for the prevention of HIV-1 infection, with future considerations for treatment., 1166, Experimental Group, MK 8527, 11 mg once a month, 24 months, MK-8527 is a novel deoxyadenosine analog with potent antiviral activity being developed for the prevention of HIV-1 infection, with future considerations for treatment., 1145,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/08/2025 Updated to align with total number of participant number. Control Group, FTC TDF, 200/245 mg, 24 months , Emtricitabine/Tenofovir Disoproxil is a combination antiretroviral medication used for the treatment and prevention of HIV-1 infection. Each film coated tablet contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate., 1100, Active-Treatment of Control Group Control Group, FTC TDF, 200/245 mg, 24 months , Emtricitabine/Tenofovir Disoproxil is a combination antiretroviral medication used for the treatment and prevention of HIV-1 infection. Each film coated tablet contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate., 1166, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 Updated to align with total number of participant number. Control Group, FTC TDF, 200/245 mg, 24 months , Emtricitabine/Tenofovir Disoproxil is a combination antiretroviral medication used for the treatment and prevention of HIV-1 infection. Each film coated tablet contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate., 1166, Active-Treatment of Control Group Control Group, FTC TDF, 200/245 mg, 24 months , Emtricitabine/Tenofovir Disoproxil is a combination antiretroviral medication used for the treatment and prevention of HIV-1 infection. Each film coated tablet contains two active ingredients: emtricitabine and tenofovir disoproxil fumarate., 1145, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/08/2025 Updated to align with total number of participant number. Control Group, Placebo, 0 mg, 24 months, A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect., 1100, Placebo Control Group, Placebo, 0 mg, 24 months, A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect., 1166, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 Updated to align with total number of participant number. Experimental Group, Placebo to FTC TDF , 0 mg, 24 months, A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect., 1145,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 Added active comparator arm. Control Group, Placebo to MK8527, 0mg, 24 months, A placebo , 1145, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 Added active comparator arm. Control Group, Placebo to MK8527, 0mg, 24 months, A placebo , 1145, Placebo Control Group, Placebo to MK8527, 0mg, 24 months, A placebo is an inactive substance or treatment designed to resemble an active medication or intervention but contains no therapeutic effect., 1145, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to Site Name and City Name. Wits RHI, 22 Esselen Street, Hillbrow, 2001, South Africa Wits RHI Ward 21 Clinical Research Site, 22 Esselen Street, Johannesburg, 2001, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to site and city name. Desmond Tutu Health Foundation, Guinea Fowl Road, Fish Hoek, 7975, South Africa DTHF Masiphumelele Clinical Research Site, Guinea Fowl Road, Cape Town , 7975, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to site and city name. Desmond Tutu Health Foundation, Cwangco Cresent, Philippi, 7781, South Africa Desmond Tutu Health Foundation Philippi Village, Cwangco Cresent, Cape Town , 7781, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name. South African Medical Research Council, 361 RK Khan Circle, Chatsworth, 4092, South Africa SA Medical Research Council Chatsworth Clinical Research Site, 361 RK Khan Circle, Chatsworth, 4092, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site and street name. Wits Maternal Adolescent and Child Health Research Unit, 40 Dr AB Xuma Street, Durban , 4001, South Africa Wits Maternal Adolescent and Child Health Research Unit WMRU, 430 Peter Mokaba Ridge, Durban , 4001, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name. Qhakaza Mbokodo Research, 15 Parklane, Ladysmith, 3370, South Africa Qhakaza Mbokodo Research Clinic, 15 Parklane, Ladysmith, 3370, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site address. CAPRISA Vulindlela Research Site, Road P402, Msunduzi, 3231, South Africa CAPRISA Vulindlela Research Site, Road P402 Ward 9 Msunduzi Municipality, Pietermaritzburg, 3231, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct street and city address. CAPRISA eThekwini Clinical Research Site, 3 University Avenue, Berea, 4001, South Africa CAPRISA eThekwini Clinical Research Site, 3 University Avenue Greyville Berea, Durban, 4001, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct city name. FPD Ndevana Community Research Site, 1270 Zintenteni, Ndevana Location, 5660, South Africa FPD Ndevana Community Research Site, 1270 Zintenteni, Ndevana , 5660, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct street address Perinatal HIV Research Unit, Chris Hani Road, Soweto, 1864, South Africa Perinatal HIV Research Unit PHRU, Chris Hani Road Diepkloof Soweto, Johnnesburg, 1864, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to site name and address Bothas Hill Clinical Research Site, No 1 Zulu Road, Bothas Hill, 3660, South Africa SA Medical Research Council Bothas Hill Clinical Research Site, 1 Zulu Reserve Road Botha s Hill Valley Trust, Durban, 3660, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name South African Medical Research, 31 to 33 Wick Street, Verulam, 4340, South Africa SA Medical Research Council Verulam Clinical Research Site, 31 to 33 Wick Street, Verulam, 4340, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name Phoenix Clinical Research, 66 Pandora Street, Phoenix, 4061, South Africa SA Medical Research Council Phoenix Clinical Research Site, 66 Pandora Street Starwood, Phoenix, 4068, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site address Synergy Biomed Research, 280 Oxford Road, East London, 5241, South Africa Synergy Biomed Research, 247 Oxford Street, East London, 5241, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site address. Umlazi Clinical Research, 1358 Mangosuthu Highway, Umlazi, 4066, South Africa Umlazi Clinical Research Site , Prince Msheyeni Memorial Hospital Philasande PMTCT Clinic 1358 Mangosuthu Highway Umlazi, Durban, 4089, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name and address. Clinical HIV Research Unit, Perth Road, Westdene, 2092, South Africa Helen Joseph Hospital Clinical HIV Research Unit, Perth Road, Johannesburg, 2092, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct site name and address. African Health Research Institute, Somkhele via R618 to Hlabisa, Mtubatu, 2925, South Africa Africa Health Research Institute AHRI Mtubatuba, AHRI CTU Somkhele Via R618 to Hlabisa, Somkhele Mtubatuba, 3935, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct city and postal code. MUJHU MITYANA, Mityana General Hospital Kikumbi Katakara Road, Mityana , , Uganda MUJHU MITYANA, Mityana General Hospital Kikumbi Katakara Road, Kampala, 256, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct street address and code. MUJHU KAMPALA, Upper Mulago Hill Road, Kampala, , Uganda MUJHU KAMPALA, Upper Mulago Hill Road Kampala, Uganda. P. O. Box 23491, Kampala, 256, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to correct city details. Infectious Diseases Institute IDI Kalangala, Kalangala Health Center IV, Kalangala Main Street, Kalangala District, , Uganda Infectious Diseases Institute IDI Kalangala, Kalangala Health Center IV, Kalangala Main Street, Kampala, 256, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Update to add postal code. MRC UVRI and LSHTM Uganda Research Unit, Plot 2 to 5 Ntikko Road, Masaka, , Uganda MRC UVRI and LSHTM Uganda Research Unit, Plot 2 to 5 Ntikko Road, Masaka, 256, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/09/2025 Added additional site details. Uganda Virus Research Institute International AIDS Vaccine Initiative UVRI IAVI, Plot 51 to 59 Nakiwogo Road P.O.BOX 49, Entebbe, 256 , Uganda
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, UNIVERSITY OF KWAZULU NATAL BIOMEDICAL RESEARCH ETHICS COMMITTEE, Westville Campus Govan Mbeki Building, Durban, 4000, South Africa, 23 Jun 2025, , 0027312602486, BREC@ukzn.ac.za, FALSE, UNIVERSITY OF KWAZULU NATAL BIOMEDICAL RESEARCH ETHICS COMMITTEE, Westville Campus Govan Mbeki Building, Durban, 4000, South Africa, 10 Jun 2025, , 0027312602486, BREC@ukzn.ac.za,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, Pharma Ethics, 123 Amkor Road, Lyttelton Manor, 0157, South Africa, 23 Jun 2025, , 0027872308460, melanie@pharma-ethics.co.za, FALSE, Pharma Ethics, 123 Amkor Road, Lyttelton Manor, 0157, South Africa, 11 Jul 2025, , 0027872308460, melanie@pharma-ethics.co.za,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, UCT HREC University of Cape Town Faculty of Health Sciences Human Research Ethics Committee, Anzio Road, Cape Town, 7925, South Africa, 23 Jun 2025, , 0027214066942, hrec-enquiries@uct.ac.za, FALSE, UCT HREC University of Cape Town Faculty of Health Sciences Human Research Ethics Committee, Anzio Road, Cape Town, 7925, South Africa, 18 Jun 2025, , 0027214066942, hrec-enquiries@uct.ac.za,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, SAMRC The South African Medical Research Council, Francie Van Zijl Drive, Cape Town, 7505, South Africa, 23 Jun 2025, , 0027219380911, info@mrc.ac.za, FALSE, SAMRC The South African Medical Research Council, Francie Van Zijl Drive, Cape Town, 7505, South Africa, 15 Jul 2025, , 0027219380911, info@mrc.ac.za,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, Wits HREC University of the Witwatersrand Human Research Ethics Committee, 31 Princess Wales Terrace , Johannesburg, 2041, South Africa, 23 Jun 2025, , 0027112749278, EthicsRegulatory@witshealth.co.za, FALSE, Wits HREC University of the Witwatersrand Human Research Ethics Committee, 31 Princess Wales Terrace , Johannesburg, 2041, South Africa, 20 Jun 2025, , 0027112749278, EthicsRegulatory@witshealth.co.za,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, UVRI Uganda Virus Research Institute Research Ethics Committee, Plot No. 51 to 59 Nakiwogo Road, Entebbe, 00256, Uganda, 23 Jun 2025, , 00256414320385, directoruvri@uvri.go.ug, FALSE, UVRI Uganda Virus Research Institute Research Ethics Committee, Plot No. 51 to 59 Nakiwogo Road, Entebbe, 00256, Uganda, 23 Jul 2025, , 00256414320385, directoruvri@uvri.go.ug,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2025 Updated to correct ethics committee address FALSE, UVRI Uganda Virus Research Institute Research Ethics Committee, Plot No. 51 to 59 Nakiwogo Road, Entebbe, 00256, Uganda, 23 Jul 2025, , 00256414320385, directoruvri@uvri.go.ug, FALSE, Uganda Virus Research Institute Research and Ethics Committee UVRI REC, Plot No. 51 to 59 Nakiwogo Road P.O.BOX 49, Entebbe, 30006, Uganda, 23 Jul 2025, , 00256414320385, directoruvri@uvri.go.ug,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date. FALSE, UNCST Uganda National Council for Science and Technology, Plot 6, Kimera Road, Ntinda, Kampala, 00256, Uganda, 23 Jun 2025, , 00256414705500, info@uncst.go.ug, FALSE, UNCST Uganda National Council for Science and Technology, Plot 6, Kimera Road, Ntinda, Kampala, 00256, Uganda, 23 Jul 2025, , 00256414705500, info@uncst.go.ug,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date and track separate site submissions to the ethics commitee. FALSE, KEMRI SERU Kenya Medical Research Institute, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 23 Jun 2025, , 00254717719477, mnjeru@kemri.org, FALSE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, , 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to add ethics approval date. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, , 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, 12 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct ethics submission date TRUE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, FALSE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, 12 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to add ethics approval date. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, , 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 27 Jun 2025, 12 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2025 Updated to add ethics approval letter. TRUE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0002 , Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, 34783_31987_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date and track separate site submissions to the ethics commitee. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0003, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, , 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to add ethics submission date. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0003, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, , 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0003, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, 12 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2025 Updated to add ethics approval letter. TRUE, KEMRI SERU Kenya Medical Research Institute Site 0003, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0003, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, 34783_33220_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date and track separate site submissions to the ethics commitee. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0006, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 19 Jun 2025, , 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to add ethics approval date. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0006, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 19 Jun 2025, , 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0006, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 19 Jun 2025, 12 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2025 Updated to add ethics approval letter. TRUE, KEMRI SERU Kenya Medical Research Institute Site 0006, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0006, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 12 Aug 2025, 00254717719477, mnjeru@kemri.org, 34783_33221_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to correct submission date and track separate site submissions to the ethics commitee. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0007, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, , 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/08/2025 Updated to add ethics approval date. FALSE, KEMRI SERU Kenya Medical Research Institute Site 0007, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, , 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0007, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, 24 Jun 2025, 11 Aug 2025, 00254717719477, mnjeru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2025 Updated to add ethics approval date. TRUE, KEMRI SERU Kenya Medical Research Institute Site 0007, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 11 Aug 2025, 00254717719477, mnjeru@kemri.org, TRUE, KEMRI SERU Kenya Medical Research Institute Site 0007, Off Mbagathi Road, House Number 8, KEMRI Headquarters, Nairobi, 00200, Kenya, , 11 Aug 2025, 00254717719477, mnjeru@kemri.org, 34783_33222_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Update to position/affiliation Scientific Enquiries, Flavia, Kiweewa, Dr., fmatovu@mujhu.org, , +256760334881, Mityana General Hospital, Kikumbi Katakara Road, Mityana, 00256, Uganda, Coordinating Principal Investigator Scientific Enquiries, Flavia, Kiweewa, Dr., fmatovu@mujhu.org, , +256760334881, Mityana General Hospital, Kikumbi Katakara Road, Mityana, 00256, Uganda, Coordinating National Principal Investigator Uganda
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Update to position/affiliation Principal Investigator, Enid, Kabugho, Dr., ekabugho@mujhu.org, , 000256772516513, Upper Mulago Hill Road Kawempe Division P.O.Box 23491 , Kampala, 10291, Uganda, Co Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Update to position/affiliation Principal Investigator, Enid, Kabugho, Dr., ekabugho@mujhu.org, , 000256772516513, Upper Mulago Hill Road Kawempe Division P.O.Box 23491 , Kampala, 10291, Uganda, Co Principal Investigator Principal Investigator, Enid, Kabugho, Dr., ekabugho@mujhu.org, , 000256772516513, Upper Mulago Hill Road Kawempe Division P.O.Box 23491 , Kampala, 10291, Uganda, Coordinating Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Update to position/affiliation Principal Investigator, Timothy, Muwonge, Dr., tmuwonge@idi.co.ug, , 256752811000, Kalangala Health Center IV Kalangala Main Street Kalangala District, Kampala, , Uganda, Coordinating Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Added Coordinating Investigator Principal Investigator, Sylvia, Kusemerewa, Dr., sylvia.kusemererwa@mrcuganda.org, , +256485660468, Plot 2-5 Ntikko Road PO. Box 1603, Masaka, 256, Uganda, Coordinating Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/09/2025 Added Coordinating Investigator Principal Investigator, Annet, Nanvubya, Dr., ananvubya@iavi.or.ug, , +256772722377, Plot 51-59, Nakiwogo Road PO Box 49, Entebe, 256, Uganda, Coordinating Investigator
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/08/2025 Updated to add description of IPD. IPD will not be provided to the public. IPD will be shared with representatives from government agencies such as Health Authorities and relevant Ethics Committees. MSD is fully committed to supporting the EFPIA and PhRMA guiding principles on data sharing, including the principle of providing qualified scientific researchers access to anonymized participant-level data and full clinical study reports (CSRs) from MSD’s clinical trials to conduct legitimate scientific research. We are also fully participating in the Institutes of Medicine (IOM) global effort to develop principles for responsible sharing of clinical trial data. Scope of Data: MSD will provide access to participant-level data and CSRs from clinical trials performed by MSD for which results are posted on the clinicaltrials.gov registry (dating back to September 2007) for products or indications that have been approved by regulators in the US and EU. In general, data will be made available for request approximately 18 months after clinical trial completion. Data from phase I trials in healthy volunteers and consumer health care studies are out of scope for this procedure.