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More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

NCT03497676 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-01-28

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Oral Cabotegravir (CAB)

30 mg tablets administered orally

DRUG

Oral Rilpivirine (RPV)

25 mg tablets administered orally

DRUG

Long-Acting Injectable Cabotegravir (CAB LA)

Administered by intramuscular (IM) injection

DRUG

Long-Acting Injectable Rilpivirine (RPV LA)

Administered by intramuscular (IM) injection

DRUG

Combination Antiretroviral Therapy (cART)

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

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Carolyn Bolton Moore, MSc, MBBCh · Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham

  • Aditya H. Gaur, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2023-02-18
Completion
2025-04-22
FDA Drug
Yes

Countries

  • United States
  • Botswana
  • South Africa
  • Thailand
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497676 on ClinicalTrials.gov