Actively Recruiting
Long-Term Follow-Up of Long-Acting Cabotegravir for HIV Pre-Exposure Prophylaxis in Participants from HPTN 083 and HPTN 084 Studies
Led by ViiV Healthcare · Updated on 2025-12-22
3508
Participants Needed
34
Research Sites
N/A
Total Duration
On this page
Sponsors
V
ViiV Healthcare
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term use of long-acting injectable cabotegravir (CAB LA) for preventing HIV infection in participants who have completed previous related studies (HPTN 083 and HPTN 084) sponsored by the Division of AIDS. The study focuses on those at risk for HIV and monitors new HIV infections, serious adverse events, and injection site reactions over an extended period. Participants in this study will continue receiving CAB LA at a dose of 600 mg administered by gluteal intramuscular injections every eight weeks. All enrolled individuals have previously received CAB LA in the parent studies or their sub-studies and will maintain this treatment schedule throughout the study period. During the study, participants will be regularly monitored for new HIV infections, serious adverse events, and any adverse reactions related to the injections or treatment that could lead to withdrawal. Follow-up will occur for up to approximately three years, with researchers collecting clinical and laboratory data to assess safety and effectiveness. Participants will have ongoing access to CAB LA under medical supervision during this long-term follow-up period.
CONDITIONS
Brief Title
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have recently completed or currently be enrolled in the CAB LA arm of HPTN 083 or HPTN 084 studies, including open label extensions and sub-studies.
- Participants who completed these studies more than 3 months ago must consult with the Medical Monitor before enrollment.
- Evidence of continued benefit from CAB LA, including being HIV negative and at risk during parent study participation.
- Nonreactive HIV tests at screening and Day 1, including rapid, immunoassay, and HIV-1 RNA tests.
- Males and females engaging in sexual activity should receive counseling on safer sex practices.
- Cisgender females of childbearing potential engaging in sexual activity must discuss contraception options; contraception is optional.
- Pregnant participants from the HPTN 084 study are eligible if all criteria are met.
- Ability and willingness to provide signed informed consent or assent where applicable.
You will not qualify if you...
- Participants currently enrolled in the TDF/FTC arm of eligible studies.
- Previous premature discontinuation from study drug in parent or sub-studies.
- Elevated liver enzymes beyond specified levels or unstable liver disease.
- Known active hepatitis B infection.
- History of cirrhosis or viral hepatitis co-infection.
- Participation in other studies with non-commercial compounds or devices within 30 days.
- Allergy or sensitivity to the study drug or components.
- Inflammatory skin conditions or dermatological issues over the injection site.
- Coagulopathy that contraindicates intramuscular injection.
- Use of prohibited medications or anticipated need for certain hepatitis C therapies.
- Likelihood of non-adherence, relocation plans, or conditions posing unacceptable risk.
- Recent symptoms suggestive of acute HIV infection.
- Being a ward of the state (e.g., child in care).
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants will receive CAB LA 600 mg via gluteal intramuscular injection every 8 weeks to reduce the risk of acquiring HIV.
Visits every 8 weeks for injections
Duration - Up to approximately 3 years
Participants are monitored for safety and any adverse effects after completing the treatment phase.
Regular follow-up visits as scheduled
Trial Site Locations
Total: 34 locations
1
GSK Investigational Site
Almagro, Argentina, C1427CEA
Actively Recruiting
2
GSK Investigational Site
Buenos Aires, Argentina, 1221
Actively Recruiting
3
GSK Investigational Site
Francistown, Botswana
Actively Recruiting
4
GSK Investigational Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
5
GSK Investigational Site
Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
6
GSK Investigational Site
São Paulo, Brazil, 04121-000
Actively Recruiting
7
GSK Investigational Site
São Paulo, Brazil, 05403-000
Actively Recruiting
8
GSK Investigational Site
Mbabane, Eswatini, H103
Actively Recruiting
9
GSK Investigational Site
Kisumu, Kenya, 40100
Actively Recruiting
10
GSK Investigational Site
Blantyre, Malawi
Actively Recruiting
11
GSK Investigational Site
Lilongwe, Malawi, CLW
Actively Recruiting
12
GSK Investigational Site
Lima, Peru, 15001
Actively Recruiting
13
GSK Investigational Site
Lima, Peru, 15024
Actively Recruiting
14
GSK Investigational Site
Lima, Peru, 15088
Actively Recruiting
15
GSK Investigational Site
Lima, Peru, Lima 04
Actively Recruiting
16
GSK Investigational Site
Piura, Peru, 20000
Actively Recruiting
17
GSK Investigational Site
Cape Town, South Africa, 7505
Completed
18
GSK Investigational Site
City of Cape Town, South Africa, 755
Actively Recruiting
19
GSK Investigational Site
City of Cape Town, South Africa, 792
Actively Recruiting
20
GSK Investigational Site
City of Johannesburg, South Africa, 2001
Actively Recruiting
21
GSK Investigational Site
Durban, South Africa, 4110
Actively Recruiting
22
GSK Investigational Site
Durban, South Africa, 4400
Actively Recruiting
23
GSK Investigational Site
Isipingo, South Africa, 4110
Actively Recruiting
24
GSK Investigational Site
Sol Plaatjie, South Africa, 8301
Actively Recruiting
25
GSK Investigational Site
Chiang Mai, Chiang Mai, Thailand, 50200
Actively Recruiting
26
GSK Investigational Site
Pathum Wan, Thailand, 10330
Actively Recruiting
27
GSK Investigational Site
Entebbe, Uganda, 49
Actively Recruiting
28
GSK Investigational Site
Kampala, Uganda
Actively Recruiting
29
GSK Investigational Site
Kampala, Uganda
Actively Recruiting
30
GSK Investigational Site
Chitungwiza, Zimbabwe, 00263
Actively Recruiting
31
GSK Investigational Site
Chitungwiza, Zimbabwe, 230221
Actively Recruiting
32
GSK Investigational Site
Chitungwiza, Zimbabwe, 263
Actively Recruiting
33
GSK Investigational Site
Harare, Zimbabwe
Actively Recruiting
34
GSK Investigational Site
Harare, Zimbabwe
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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