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NCT02771249 · ClinicalTrials.gov registry record · Phase 1
Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers
A Phase 1 study of HIV Infected Population With Latent Tuberculosis, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT02771249: Completed Phase 1 study of HIV Infected Population With Latent Tuberculosis, sponsored by National Institutes of Health Clinical Center (CC).
NCT02771249 is a Phase 1 study of HIV Infected Population With Latent Tuberculosis that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02771249, a Phase 1 study of HIV Infected Population With Latent Tuberculosis, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekly treatment for latent TB would be easier for people with HIV to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid. However, they need to see how TB drugs and HIV drugs interact. Objective: To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely. Eligibility: Healthy adults ages 18 65. Design: Participants will be screened with a medical history and physical exam. They will have vital signs taken and give a blood sample. Women will have a pregnancy test. Participants cannot take any other medicines during the study, including vitamins. Only occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl , Zyrtec , Claritin , etc.) will be allowed. Participants will be assigned to one of three groups. Each group will take a different study drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a supply of the study drug tablets and instructions for taking them. Participants will keep a medicine diary to serve as a memory aid for taking medicine and reporting any side effects that they may experience. Participants will have 8 or 9 study visits over about 40 days. The number of visits depends on which group the person is assigned to. All visits will take place at the NIH Clinical Center. Participants will fast before study visits. The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last for about 12 hours. The other 4-5 visits will last about 1 hour. During all study visits, screening
Primary Outcome
To assess the effects of once weekly administration of RPT and INH given at doses used for treating LTBI on the steady state PK of DRV/c
Conditions Studied
Interventions
- DRUG rifapentene (RPT)
- DRUG darunavir/cobicistat (DRV/c)
- DRUG Isoniazid (INH)
- DIETARY_SUPPLEMENT Pyridoxine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-06-03 |
| Est. Completion | 2021-08-17 |
| Phase | Phase 1 |
What the finished NCT02771249 record still lists
NCT02771249 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 1 condition, with HIV Infected Population With Latent Tuberculosis appearing as the primary indexed condition, and to 4 interventions - of which rifapentene (RPT) is the first listed.
NCT02771249 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02771249 about?
NCT02771249 is a clinical study titled "Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers". People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekl...
What is the current status of trial NCT02771249?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2016-06-03. Estimated completion is 2021-08-17.
What conditions does trial NCT02771249 study?
This clinical trial studies the following conditions: HIV Infected Population With Latent Tuberculosis.
What interventions are being tested in trial NCT02771249?
The interventions under investigation include: rifapentene (RPT) (DRUG), darunavir/cobicistat (DRV/c) (DRUG), Isoniazid (INH) (DRUG), Pyridoxine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02771249?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02771249 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02771249's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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
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