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.: PACTR202404524950258 Date of Approval: 12/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TMC278LAHTX4002: A Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection.
Official scientific title A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-acting.
Brief summary describing the background and objectives of the trial The purpose of this study is to provide continued access to Cabotegravir Long-acting injection (CAB LA) and Rilpivirine Long-acting injection (RPV LA) for participants who were included in the clinical development studies for CAB LA and RPV LA and who, at the time of roll-over, experience a clinical benefit from the treatment. Cabotegravir (CAB) is an integrase strand transfer inhibitor (INSTI), formulated as a long-acting (LA) parenteral product. Rilpivirine (RPV), also formulated as a LA product, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type HIV-1 and select NNRTI-resistant mutants. This is a Phase 4, non-randomized, open-label, multicenter, multicountry, rollover study in participants living with HIV-1 infection who were treated in the parent studies with CAB LA + RPV LA given intramuscularly on a Q4W or Q8W dosing schedule. The purpose of the study is to provide continued access to the CAB LA + RPV LA to participants, who were included in the clinical development studies for CAB LA + RPV LA (NCT03497676, NCT05660980, IMPAACT 2040 [CREATE], PACTR202104874490818, NCT05546242), and who, at the time of rollover, experience clinical benefit from this treatment. This study also allows for the evaluation of the long-term safety and tolerability of CAB LA + RPV LA in participants. The study will include a rollover visit (must occur at or after the last study visit for the parent study), a treatment phase, and end of study/final/withdrawal visit when the participant meets one of the withdrawal criteria, or when the participant has completed the roll-over study. Safety assessments include physical examination, vital signs, adverse events and serious adverse events monitoring, and pregnancies/abnormal pregnancy outcomes reporting. The total duration of the study will be up to 4 years (48 months).
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/05/2024
Actual trial start date
Anticipated date of last follow up 30/06/2030
Actual Last follow-up date
Anticipated target sample size (number of participants) 710
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
202300106426 EMA - EudraCT
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
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cabotegravir Long acting Injection and Rilpivirine Long acting Injection CAB LA and RPV LA up to 48 months Participants will continue to receive CAB LA and RPV LA as per the same regimen as they received in any of the parent studies (IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], IMPAACT 2040 [CREATE], TMC278LAHTX3002 [CARES], TMC278LAHTX3005 [IMPALA]) for up to 48 months. 710
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants (or their legally acceptable representative) must sign an informed consent form indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study Participants living with HIV-1 infection who were treated with CAB LA + RPV LA in any of the following parent studies: TMC278LAHTX3002 (CARES), TMC278LAHTX3005 (IMPALA), IMPAACT 2017 (MOCHA), IMPAACT 2036 (CRAYON), IMPAACT 2040 (CREATE), and completed the protocol-defined treatment period - Has benefited clinically from treatment with CAB LA + RPV LA in the opinion of the investigator - Must be able and willing to comply with the rollover protocol requirements - Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study Participants using disallowed concomitant treatment Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 100 Year(s) Both
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 12/02/2024 Botswana Health Research and Development Committee HRDC
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Private Bag 0038 Gaborone 0038 Botswana
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 31/03/2024 Pharmacy and Poisons Board Kenya
Ethics Committee Address
Street address City Postal code Country
Lenana Road opp DOD Nairobi 27663-005 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
No 22/04/2024 National Drug Authority Uganda
Ethics Committee Address
Street address City Postal code Country
Plot 93, Buganda Road , after St. Catherine Hospital Kampala 23096 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 26/02/2024 Wits Health Consortium
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace, Parktown Gauteng 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of Participants Who Continued to Receive Cabotegravir and Rilpivirine Long-Acting Injections Up to 48 months throughout the study
Secondary Outcome Number of Participants with Adverse Events (AEs) Related to Study Intervention Up to 48 months throughout the study
Secondary Outcome Number of Participants with AEs Leading to Discontinuation Up to 48 months throughout the study
Secondary Outcome Number of Participants with Serious Adverse Events (SAEs) Up to 48 months throughout the study
Secondary Outcome Number of Participants with Pregnancies Up to 48 months throughout the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BOTSWANA HARVARD AIDS INSTITUTE Scottish Livingstone Hospital Molepolole Gaborone Road Molepolol Kweneng District Botswana Molepolole Botswana
BOTSWANA HARVARD AIDS INSTITUTE Plot 1836 North Ring Road Princess Marina Hospital Grounds Gaborone Botswana
AGA KHAN HOSPITAL 3rd Parklands Avenue Nairobi Kenya
Moi University Malaba Road Eldoret Kenya
KEMRI Branch Kenya Medical Research Institute Walter Reed Program Clinical Research Site Kericho Kenya
Kenyatta National Hospital Off-Ngong Road University of Nairobi College of Health Sciences Nairobi Kenya
Jaramogi Oginga Odinga Teaching Referral Hospital Jomo Kenyatta Highway Kaloleni Kisumu PO Box 849 Central Kenya
Joint Clinical Research Centre Plot 101 Lubowa P O Box 10005 Kampala Uganda
Infectious Diseases Institute Hall Lane Kampala Uganda
Baylor College of Medicine Childrens Foundation Uganda P O Box 72052 New Mulago Gate Road Kampala Uganda
MUJHU Research Collaboration Upper Mulago Hill Road P O BOX 23491 Kampala Uganda
Medical Research Council Uganda Virus Research Institute Research Unit on AIDS MRC UVRI Plot 51 59 Nakiwogo Road Entebbe Uganda
CAPRISA Umlazi Clinical Research Site 1358 Mangosuthu Highway Philasande Clinic Prince Mshiyeni Memorial Hospital Umlazi South Africa
Ezintsha 32 Princess of Wales Terrace Parktown Johannesburg South Africa
Perinatal HIV Research Unit Old Potch Road 12th Floor Chris Baragwanath Hospital Soweto South Africa
Shandukani Research Centre Cnr Esselen and Klein Street 2nd floor Hillbrow Health Precinct WITS RHI Johannesburg South Africa
Family Clinical Research Unit FAM CRU Francie Van Zyl Ave Ward J8 Tygerberg Hospital Department of Paediatrics and Child Health Tygerberg South Africa
South African Medical Research Council Chatsworth Clinical Research Site HIV Prevention Research Unit, RK Khan Circle, Chatsworth KwaZulu Natal South Africa
Centre for the AIDS Programme of Research in South Africa 791 Umbilo Road 2nd Floor Doris Duke Medical Research Institute Nelson R Mandla School of Medicine Congella Congella South Africa
Desmond Tutu HIV Foundation Old Main Road Building Groote Schuur Hospital-Main Road Cape Town South Africa
Joint Clinical Research Centre Main PO Box 10005 central region Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Cilag International NV Turnhoutseweg 30 B 2340 Beerse Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Janssen Cilag International NV Turnhoutseweg 30 B 2340 Beerse Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cissy Kityo Mutuluuza ckityo@jcrc.org.ug +254702745306 Plot 101 Lubowa off Entebbe road
City Postal code Country Position/Affiliation
Kampala 10005 Uganda National coordinating investigator
Role Name Email Phone Street address
Public Enquiries Fridah Mwendia fmwendia@its.jnj.com +254702745306 Johnson and Johnson Middle East FZ-LLC Avenue Five Building, 5th Floor, Rose Avenue Off Lenana Road
City Postal code Country Position/Affiliation
Nairobi 0010 Kenya Clinical Research Manager
Role Name Email Phone Street address
Scientific Enquiries Fridah Mwendia fmwendia@its.jnj.com +254702745306 Johnson and Johnson Middle East FZ-LLC Avenue Five Building, 5th Floor, Rose Avenue Off Lenana Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Clinical Research Manager
Role Name Email Phone Street address
Public Enquiries Nomfundo Nomonde Cele ncele1@its.jnj.com +27723190108 2 Medical Road Midrand
City Postal code Country Position/Affiliation
Gauteng 1685 South Africa Regional Trial Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu URL : https://www.janssen.com/clinical-trials/transparency Clinical Study Report,Statistical Analysis Plan,Study Protocol Beginning 18 months after last patient, last visit and EU and US approvals. No end date. • Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. • To achieve aims in the approved proposal. • All of the individual participant data collected during the trial, after de-identification. • Proposals should be directed to https://yoda.yale.edu/. To gain access, once the proposal is approved, data requestors will need to sign a data access agreement. Data are available for 1- year (extendable by agreed extension) thorough the YODA Project process.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.janssen.com/clinical-trials/transparency 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