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HIV prevention shot under Long-Term watch in 3,500 volunteers

NCT ID NCT06134362

Prevention Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study is checking the long-term safety and effectiveness of a long-acting injectable drug called cabotegravir (CAB LA) for preventing HIV. It includes about 3,500 people who already received CAB LA in earlier HIV prevention studies. Participants will continue getting the shots and be monitored for new HIV infections, serious side effects, and injection site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,996 people

The number who actually took part.

Started

May 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Type of participant 1. Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm: * HPTN 083 open label extension * HPTN 084 open label extension (including pregnancy sub-study) Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment. Participants who have prematurely 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 nonreactive HIV tests at Screening (rapid test, immunoassay \[antigen/antibody\] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and immunoassay \[antigen/antibody test\] results must be available and nonreactive). Participants who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates they are not HIV-infected. Sex 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. Females: Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options. Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria. Informed consent 5. Participant or caregiver/legal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent. Exclusion Criteria: Concurrent conditions/medical history (includes liver function) 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 premature discontinuation from IP in the parent study/sub-study. 3. ALT \>5 × ULN; or ALT\>3 × ULN and bilirubin \>1.5 × ULN (with \>35% direct bilirubin) in the screening liver chemistry test result. 4. Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. 5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator). 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) with a compound or device that is not commercially available within 30 days prior to signing informed consent, unless permission from the Medical Monitor is granted. 8. Presence of or any history of allergy/sensitivity to the study drug or its components. 9. Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee. 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. Concomitant medications 12. Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication. 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. Relevant habits 14. Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 15. Any condition (i(including but not limited to substance use disorder) 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. Other 16. Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results using appropriate HIV tests as per Inclusion Criterion #3. 17. Participant is a ward of the state (e.g. child in care).

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • GSK Investigational Site

    Almagro, C1427CEA, Argentina

  • GSK Investigational Site

    Buenos Aires, 1221, Argentina

  • GSK Investigational Site

    Francistown, Botswana

  • GSK Investigational Site

    Porto Alegre, 91350-200, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 21040-360, Brazil

  • GSK Investigational Site

    São Paulo, 04121-000, Brazil

  • GSK Investigational Site

    São Paulo, 05403-000, Brazil

  • GSK Investigational Site

    Mbabane, H103, Eswatini

  • GSK Investigational Site

    Kisumu, 40100, Kenya

  • GSK Investigational Site

    Blantyre, Malawi

  • GSK Investigational Site

    Lilongwe, CLW, Malawi

  • GSK Investigational Site

    Lima, 15001, Peru

  • GSK Investigational Site

    Lima, 15024, Peru

  • GSK Investigational Site

    Lima, 15088, Peru

  • GSK Investigational Site

    Lima, Lima 04, Peru

  • GSK Investigational Site

    Piura, 20000, Peru

  • GSK Investigational Site

    Cape Town, 7505, South Africa

  • GSK Investigational Site

    City of Cape Town, 755, South Africa

  • GSK Investigational Site

    City of Cape Town, 792, South Africa

  • GSK Investigational Site

    City of Johannesburg, 2001, South Africa

  • GSK Investigational Site

    Durban, 4110, South Africa

  • GSK Investigational Site

    Durban, 4400, South Africa

  • GSK Investigational Site

    Isipingo, 4110, South Africa

  • GSK Investigational Site

    Sol Plaatjie, 8301, South Africa

  • GSK Investigational Site

    Chiang Mai, Chiang Mai, 50200, Thailand

  • GSK Investigational Site

    Pathum Wan, 10330, Thailand

  • GSK Investigational Site

    Entebbe, 49, Uganda

  • GSK Investigational Site

    Kampala, Uganda

  • GSK Investigational Site

    Hanoi, Vietnam

  • GSK Investigational Site

    Chitungwiza, 00263, Zimbabwe

  • GSK Investigational Site

    Chitungwiza, 230221, Zimbabwe

  • GSK Investigational Site

    Chitungwiza, 263, Zimbabwe

  • GSK Investigational Site

    Harare, Zimbabwe

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