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)

NCT06134362 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 221163
• Study Type: interventional
• Target: 3,508
• Locations: 11 countries
• Sites: 34

Brief Summary

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

HIV Infections

Keywords

HIV; Human Immunodeficiency Virus; CAB LA; Cabotegravir; Apretude; PrEP; HPTN 083; HPTN 084; DAIDS

Outcome Measures

Primary Outcomes (2)

• Number of participants with new HIV infection

  From Day 1 up to end of study (up to approximately [approx.] 3 years)

• Number of participants with new HIV infection by characteristic

  Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB.

  From Day 1 up to end of study (up to approx. 3 years)

Secondary Outcomes (3)

• Number of participants with serious adverse events (SAE) by severity

  From Day 1 up to end of study (up to approx. 3 years)

• Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)

  From Day 1 up to end of study (up to approx. 3 years)

• Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity

  From Day 1 up to end of study (up to approx. 3 years)

Study Arms (1)

CAB LA 600 mg (Q8W)

EXPERIMENTAL

All enrolled participants have previously received CAB LA as part of the HPTN 083 and HPTN 084 parent studies or their sub-studies. Participants will continue receiving CAB LA 600 mg via gluteal intramuscular (IM) injection.

Drug: CAB LA

Interventions

CAB LA DRUG

Participants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).

Also known as: Apretude, CAB LA for PrEP

CAB LA 600 mg (Q8W)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of participant
• 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.
• Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
• 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
• 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

You may not qualify if:

• Concurrent conditions/medical history (includes liver function)
• 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.
• Previous premature discontinuation from IP in the parent study/sub-study.
• ALT \>5 × ULN; or ALT\>3 × ULN and bilirubin \>1.5 × ULN (with \>35% direct bilirubin) in the screening liver chemistry test result.
• 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.
• 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).
• Known history of cirrhosis with or without viral hepatitis co-infection.
• Presence of or any history of allergy/sensitivity to the study drug or its components.
• 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.
• Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications
• Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.
• 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
• Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• PPD Development, LP: collaborator
• ViiV Healthcare: lead

Study Sites (34)

GSK Investigational Site

Almagro, C1427CEA, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, 1221, Argentina

RECRUITING

GSK Investigational Site

Francistown, Botswana

RECRUITING

GSK Investigational Site

Porto Alegre, 91350-200, Brazil

RECRUITING

GSK Investigational Site

Rio de Janeiro, 21040-360, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 04121-000, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 05403-000, Brazil

RECRUITING

GSK Investigational Site

Mbabane, H103, Eswatini

RECRUITING

GSK Investigational Site

Kisumu, 40100, Kenya

RECRUITING

GSK Investigational Site

Blantyre, Malawi

RECRUITING

GSK Investigational Site

Lilongwe, CLW, Malawi

RECRUITING

GSK Investigational Site

Lima, 15001, Peru

RECRUITING

GSK Investigational Site

Lima, 15024, Peru

RECRUITING

GSK Investigational Site

Lima, 15088, Peru

RECRUITING

GSK Investigational Site

Lima, Lima 04, Peru

RECRUITING

GSK Investigational Site

Piura, 20000, Peru

RECRUITING

GSK Investigational Site

Cape Town, 7505, South Africa

COMPLETED

GSK Investigational Site

City of Cape Town, 755, South Africa

RECRUITING

GSK Investigational Site

City of Cape Town, 792, South Africa

RECRUITING

GSK Investigational Site

City of Johannesburg, 2001, South Africa

RECRUITING

GSK Investigational Site

Durban, 4110, South Africa

RECRUITING

GSK Investigational Site

Durban, 4400, South Africa

RECRUITING

GSK Investigational Site

Isipingo, 4110, South Africa

RECRUITING

GSK Investigational Site

Sol Plaatjie, 8301, South Africa

RECRUITING

GSK Investigational Site

Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

GSK Investigational Site

Pathum Wan, 10330, Thailand

RECRUITING

GSK Investigational Site

Entebbe, 49, Uganda

RECRUITING

GSK Investigational Site

Kampala, Uganda

RECRUITING

GSK Investigational Site

Kampala, Uganda

RECRUITING

GSK Investigational Site

Chitungwiza, 00263, Zimbabwe

RECRUITING

GSK Investigational Site

Chitungwiza, 230221, Zimbabwe

RECRUITING

GSK Investigational Site

Chitungwiza, 263, Zimbabwe

RECRUITING

GSK Investigational Site

Harare, Zimbabwe

RECRUITING

GSK Investigational Site

Harare, Zimbabwe

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: May 14, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

KE (1); BR (4); AR (2); ES (1); ZA (8); TH (2); MA (2); UG (3); ZI (5); PE (5); BO (1)