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Antiretroviral

Pharmacokinetic study in healthy volunteers for Healthy Subjects

Phase 1
Waitlist Available
Led By Joseph A Kovacs, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 14-15, 22-23, and 31-32 at 0 (pre dose), 0.25,0.5,1,2,4,6,8 and 24 hours post dose.
Awards & highlights

Study Summary

This trial is studying how rifapentine and isoniazid affect blood levels of TAF, a common antiretroviral drug, in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 14-15, 22-23, and 31-32 at 0 (pre dose), 0.25,0.5,1,2,4,6,8 and 24 hours post dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 14-15, 22-23, and 31-32 at 0 (pre dose), 0.25,0.5,1,2,4,6,8 and 24 hours post dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Secondary outcome measures
(1) Intracellular AUC0-24hr and t (Omega) for TFV-dp. (2) AEs and abnormal laboratory values, as graded according to the DAIDS AE table and the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Tri...

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pharmacokinetic study in healthy volunteersExperimental Treatment4 Interventions
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir alafenamide
2002
Completed Phase 3
~260
Rifapentine
2002
Completed Phase 3
~1940
Isoniazid (INH)
2016
Completed Phase 4
~4110
Pyridoxine
2017
Completed Phase 4
~900

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
880,951 Total Patients Enrolled
Joseph A Kovacs, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
11 Previous Clinical Trials
3,766 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolment for this research still open?

"Clinicialtrials.gov confirms that this medical trial, initiated on June 12th of 2018, is still actively recruiting participants. The most recent update was posted on July 27th 2022."

Answered by AI

Does this clinical trial admit participants aged 85 and older?

"This research requires that participants be between 18 and 65 years old. Alternatively, there are 66 studies for those under the legal age of adulthood and 458 medical trials available to patients over the elder cutoff."

Answered by AI

What demographic is best suited to engage in this experiment?

"This clinical study is currently recruiting 75 volunteers aged 18-65 who weigh between 45 and 120 kilograms or have a body mass index of greater than 18.0 but less than 30. Additionally, participants must be willing to abstain from alcohol consumption for the duration of the trial period."

Answered by AI

What sorts of conditions has Priftin (rifapentine) been successful in alleviating?

"Priftin (rifapentine) is a viable treatment option for patients who have been virologically supressed, prescribed tenofovir, and experienced prior treatment failure."

Answered by AI

Is the administration of Priftin (rifapentine) associated with any adverse effects?

"Priftin (rifapentine) is in the early stages of clinical research, so it received a score of 1. This indicates that there exists relatively sparse data concerning both efficacy and safety."

Answered by AI

What is the sample size of this medical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is actively searching for volunteers; it was initially posted on June 12th 2018 and the most recent update occurred July 27th 2022. The project needs 75 individuals at a single location in order to be completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
2018. "Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03510468.
~7 spots leftby Apr 2025
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