Actively Recruiting
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)
Led by ViiV Healthcare · Updated on 2025-12-22
3508
Participants Needed
34
Research Sites
241 weeks
Total Duration
On this page
Sponsors
V
ViiV Healthcare
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
CONDITIONS
Official 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 be currently enrolled in the CAB LA arm of HPTN 083 or HPTN 084 studies or their open label extensions
- Participants must be HIV negative at screening and Day 1 with nonreactive HIV tests
- Participants must show evidence of continued benefit from CAB LA during the parent study
- Males and females who are sexually active should be counseled on safer sexual practices
- Females of childbearing potential who are sexually active must discuss contraception options with the investigator; contraception is optional
- Pregnant participants from HPTN 084 are eligible if all criteria are met
- Participants or their caregivers/legal guardians must be able and willing to provide signed informed consent
You will not qualify if you...
- Participants currently enrolled in the TDF/FTC arm of eligible studies are not eligible
- Previous premature discontinuation from investigational product in parent study
- Elevated liver enzymes (ALT >5x upper limit or ALT >3x upper limit with bilirubin >1.5x upper limit and >35% direct bilirubin) at screening
- Known active hepatitis B infection
- Unstable liver disease or known biliary abnormalities except stable chronic liver disease
- History of cirrhosis with or without viral hepatitis co-infection
- Participation in other studies with non-commercially available compounds or devices within 30 days prior to consent without Medical Monitor permission
- Allergy or sensitivity to study drug or components
- Inflammatory skin conditions compromising injection safety
- Gluteal implants, tattoos, or dermatological conditions interfering with injections or reaction assessments
- Coagulopathy contraindicating intramuscular injection
- Use of prohibited medications without willingness or ability to switch
- Anticipated need for hepatitis C virus therapy with interferon or interacting drugs during study
- Unlikely to adhere to study procedures or planning to relocate
- Conditions placing participant at unacceptable risk or inability to meet protocol requirements
- Signs or symptoms suggestive of acute HIV infection within 14 days prior to screening
- Participant is a ward of the state (e.g., child in care)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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