At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
Oral cabotegravir (CAB) +2 moredrug
Likely dose
Oral cabotegravir (CAB) 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 Females - A Sub-study of HPTN 084
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 1, 2021·Updated Dec 3, 2024
In Brief
A Phase 2 clinical trial evaluating Oral cabotegravir (CAB), CAB LA, and 1 other intervention for HIV Infections. Completed, enrolled 55 participants across 3 sites in 3 countries.
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
CountriesSouth Africa, Uganda, Zimbabwe
CollaboratorsViiV Healthcare, Bill and Melinda Gates Foundation
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartNov 2020
First PostedApr 2021
Primary CompletionJan 2023
TodayJul 2026
First PostedApr 1, 2021
Enrollment StartNov 4, 2020
Primary CompletionJan 10, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.3 years ago
Interventions
Oral cabotegravir (CAB)drug
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
Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)drug
300 mg/200 mg fixed-dose combination tablets