NCT02771249

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Completed Phase 1 Last updated 18 April 2022

What this trial tests

Phase 1 trial testing rifapentene (RPT) in HIV Infected Population With Latent Tuberculosis in 37 participants. Completed in 17 August 2021.

Timeline

3 June 2016

Primary endpoint
17 August 2021

17 August 2021

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	37
Start date	3 June 2016
Primary completion	17 August 2021
Estimated completion	17 August 2021
Sites	1 location across United States

Drugs / interventions tested

• rifapentene (RPT) — full drug profile →
• darunavir/cobicistat (DRV/c) — full drug profile →
• Isoniazid (INH) — full drug profile →
• Pyridoxine (PYRIDOXINE) — full drug profile →

Conditions studied

• HIV Infected Population With Latent Tuberculosis — all drugs for HIV Infected Population With Latent Tuberculosis →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 65, any sex, with HIV Infected Population With Latent Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 procedures will be repeated. During long visits, an intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to take blood.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical standards for the diagnosis, treatment and prevention of TB infection.
   Migliori GB, Wu SJ, Matteelli A, Zenner D, et al · · 2022 · cited 55× · PMID 35197159 · DOI 10.5588/ijtld.21.0753
2. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.
   Brooks KM, George JM, Pau AK, Rupert A, et al · · 2018 · cited 46× · PMID 29415190 · DOI 10.1093/cid/ciy082
3. Pharmacokinetics, Safety, and Tolerability of Once-Daily Darunavir With Cobicistat and Weekly Isoniazid/Rifapentine.
   Brooks KM, Pau AK, Swaim D, Bunn HT, et al · · 2023 · cited 2× · PMID 37955446 · DOI 10.1097/qai.0000000000003301