Actively Recruiting

Phase 3
All Genders
Healthy Volunteers
ID06134362

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

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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