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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03497676
The ClinicalTrials.gov registry entry for NCT03497676 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Oral Cabotegravir (CAB) is the first listed.
NCT03497676 reports 0 study locations.
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.
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