Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202404510501536

Enrollment

Registered

2024-04-10

Start date

2024-05-31

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Cabotegravir Long Acting or CAB LA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must be currently enrolled and ongoing in one of the following studies: HPTN 083, HPTN 084, HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies. Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study. 2.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 a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]). 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. 5. Participant or caregiver is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.	—

Secondary

Measure	Time frame
To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.	—

Countries

Kenya

Contacts

Public ContactGrace Mboya

Investigator KEMRI Kisumu CRS

GMboya@kemri.go.ke+254705300452

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026