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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404510501536 Date of Registration: 10/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
Official scientific title Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
Brief summary describing the background and objectives of the trial Cabotegravir long-acting (CAB LA) for PrEP has, in previous clinical studies, demonstrated superior efficacy to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in reducing the risk of HIV acquisition. The medicine was studied in transgender women and men who have sex with men (HPTN 083 study), as well as cisgender women (HPTN 084 study) who were at increased risk of sexually acquiring HIV. Long-term follow-up studies are routinely conducted in order to look at how well a new intervention works over a longer period of time, as well as to look for side effects that may not have been seen in earlier studies. The purpose of this study is long-term evaluation of participants receiving CAB LA who are at risk of acquiring HIV. Participants will transition from the DAIDS sponsored PrEP studies HPTN 083 and HPTN 084 parent studies and associated sub-studies (the ‘parent studies’) into this study. Participants will continue to receive CAB LA and be followed for new HIV diagnosis and safety as specified in the protocol. Eligible participants will be HIV negative at the last visit in the parent studies and will have tolerated CAB LA without significant toxicities. Objective: 1. To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies 2. To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.
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 Prevention
Anticipated trial start date 31/05/2024
Actual trial start date
Anticipated date of last follow up 31/05/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 55
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
221163 Sponsor
PALISADE Sponsor
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 or CAB LA 600 mg Up to 3 years or until CAB LA receives local regulatory approval (by country) and is available in those countries, or until other access occurs from another source (e.g., government programs, aid programs, assistance programs, commercial availability, etc.), or if the participant no longer benefits from CAB LA, or meets a protocol defined stopping criteria. Extended-release injectable suspension for gluteal intramuscular injection once every 8 weeks (Q8W) 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants must be currently enrolled and ongoing in one of the following studies: HPTN 083, HPTN 084, HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies. Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study. 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]). 4. Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs. 5. Participant or caregiver is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. 1. Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
1. Participants must be currently enrolled and ongoing in one of the following studies: HPTN 083, HPTN 084, HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies. Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study. 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]). 4. Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs. 5. Participant or caregiver is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. 1. Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor. 2. Previous permanent discontinuation from IP in the parent study/sub-study. 3. Known ALT >5 x ULN or ALT>3 x ULN and bilirubin >1.5 x ULN (with >35% direct bilirubin). 4. Participants with known hepatitis B infection at any time prior to entry. 5. Unstable liver disease as defined within the protocol. 6. Known history of cirrhosis with or without viral hepatitis co-infection. 7. Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) within 30 days of signing informed consent. 8. Presence of any history of allergy/sensitivity to any of the study drug. 9. Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. 10. Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs. 11. Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. 12. Use of any disallowed medications at time of screening. 13. Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug:drug interactions with study treatment throughout the entire study period. 14. Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 15. Any condition (including but not limited to alcohol and drug use) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 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 17/10/2023 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
Off Raila Ondiga Way Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies. From Day 1 to 3 years, or until local commercial availability of CAB LA
Secondary Outcome To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies. From Day 1 to 3 years, or until local commercial availability of CAB LA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Kisumu CRS Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road, P.O. Box 1578 Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
ViiV Healthcare UK Limited 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grace Mboya GMboya@kemri.go.ke +254705300452 Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Investigator KEMRI Kisumu CRS
Role Name Email Phone Street address
Public Enquiries Grace Mboya GMboya@kemri.go.ke +254705300452 Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Investigator KEMRI Kisumu CRS
Role Name Email Phone Street address
Scientific Enquiries Grace Mboya GMboya@kemri.go.ke +254705300452 Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Investigator KEMRI Kisumu CRS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized participant-level data sets will be made available for external data sharing within 18 months of the last participant last visit (LPLV) globally and in accordance with the sponsor’s SOPs. Clinical Study Report,Informed Consent Form,Study Protocol Within 18 months of the last participant last visit (LPLV) globally and in accordance with the sponsor’s SOPs. Refer to https://vivli.org/ for data request process overview.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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