Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03497676 · ClinicalTrials.gov registry record · Phase 1
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
NCT03497676: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03497676 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 168 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497676, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
Study 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.
Primary Outcome
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 ind
Interventions
- DRUG Oral Cabotegravir (CAB)
- DRUG Oral Rilpivirine (RPV)
- DRUG Long-Acting Injectable Cabotegravir (CAB LA)
- DRUG Long-Acting Injectable Rilpivirine (RPV LA)
- DRUG Combination Antiretroviral Therapy (cART)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2019-04-03 |
| Est. Completion | 2025-04-22 |
| Phase | Phase 1 |
What the finished NCT03497676 record still lists
NCT03497676 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 5 interventions - of which Oral Cabotegravir (CAB) is the first listed.
NCT03497676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497676 about?
NCT03497676 is a clinical study titled "More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents". 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 chi...
What is the current status of trial NCT03497676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2019-04-03. Estimated completion is 2025-04-22.
What interventions are being tested in trial NCT03497676?
The interventions under investigation include: Oral Cabotegravir (CAB) (DRUG), Oral Rilpivirine (RPV) (DRUG), Long-Acting Injectable Cabotegravir (CAB LA) (DRUG), Long-Acting Injectable Rilpivirine (RPV LA) (DRUG), Combination Antiretroviral Therapy (cART) (DRUG).
Who is sponsoring clinical trial NCT03497676?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03497676's enrollment target sits among peer trials
168 326th of 2000 higher than 1,671 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02118922 · 168 participants
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
- NCT03536897 · 168 participants
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
- NCT04078230 · 168 participants · NA
Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
- NCT04159168 · 168 participants · NA
Facial Affect Sensitivity Training for Young Children With Callous-unemotional Traits
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI