At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
Cabotegravir (CAB) tablet +2 moredrug
Likely dose
Cabotegravir (CAB) tablet 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 31, 2020·Updated May 20, 2025
In Brief
A Phase 2 clinical trial evaluating Cabotegravir (CAB) tablet, CAB LA, and 1 other intervention for HIV Infections. Completed, enrolled 9 participants across 4 sites.
Detailed Summary
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartFeb 2020
First PostedDec 2020
Primary CompletionJul 2023
TodayJul 2026
First PostedDec 31, 2020
Enrollment StartFeb 19, 2020
Primary CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.5 years ago
Interventions
Cabotegravir (CAB) tabletdrug
30 mg tablets
CAB LAdrug
Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter.
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tabletdrug
300 mg/200 mg fixed-dose combination tablets