CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Oral Cabotegravir (CAB) +4 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.

Search/NCT03497676
NCT03497676Phase 2Completed
CompareCT.gov

Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 13, 2018·Updated Jan 28, 2026

In Brief

A Phase 2 clinical trial evaluating Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), and 3 other interventions for HIV Infections. Completed, enrolled 168 participants across 19 sites in 5 countries.

Detailed Summary

The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, South Africa, Thailand, Uganda, United States
CollaboratorsViiV Healthcare

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 13, 2018
Enrollment StartApr 3, 2019
Primary CompletionFeb 18, 2023
Study CompletionApr 22, 2025
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.2 years ago

Interventions

Oral Cabotegravir (CAB)drug

30 mg tablets administered orally

Oral Rilpivirine (RPV)drug

25 mg tablets administered orally

Long-Acting Injectable Cabotegravir (CAB LA)drug

Administered by intramuscular (IM) injection

Long-Acting Injectable Rilpivirine (RPV LA)drug

Administered by intramuscular (IM) injection

Combination Antiretroviral Therapy (cART)drug

Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.