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NCT04272242 · ClinicalTrials.gov registry record · Phase 2
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT04272242: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04272242 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04272242, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study evaluated the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT was given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.
Primary Outcome
This evaluates the effect of RPT on the DTG PK parameter Cmax obtained from participants enrolled in Arm 1 at day 0 (DTG QD) and day 28 (DTG BID with 1HP). Cmax defines the model-predicted maximum concentration observed over the 12- or 24- hours of the DTG dosing interval.
Interventions
- DRUG Dolutegravir (DTG)
- DRUG Isoniazid (INH)
- DRUG Rifapentine (RPT)
- DIETARY_SUPPLEMENT Pyridoxine (Vitamin B6)
- DRUG Antiretroviral Therapy (ART)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-02-27 |
| Est. Completion | 2021-12-27 |
| Phase | Phase 2 |
Why NCT04272242 stopped before completion
NCT04272242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Dolutegravir (DTG) is the first listed.
NCT04272242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04272242 about?
NCT04272242 is a clinical study titled "Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals". This study evaluated the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT was given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.
What is the current status of trial NCT04272242?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2021-02-27. Estimated completion is 2021-12-27.
What interventions are being tested in trial NCT04272242?
The interventions under investigation include: Dolutegravir (DTG) (DRUG), Isoniazid (INH) (DRUG), Rifapentine (RPT) (DRUG), Pyridoxine (Vitamin B6) (DIETARY_SUPPLEMENT), Antiretroviral Therapy (ART) (DRUG).
Who is sponsoring clinical trial NCT04272242?
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 NCT04272242's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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