Investigational Site Number 840001
Buffalo, New York, 14202, United States
NCT Number: NCT01690403
Primary Objective:
- To evaluate the effect of single and repeated administration of rifapentine given as daily or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and tenofovir given as a fixed dose combination (ATRIPLA™ ).
Secondary Objective:
- To evaluate the safety and tolerability of concomitant administration of rifapentine and ATRIPLA™ given to HIV+ patients
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Buffalo, New York, 14202, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form:tablet
Route of administration: oral
Pharmaceutical form:tablet
Route of administration: oral
Other names: ATRIPLA™
Time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2
Time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
Time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
Time frame: Day -2 and Day 1 for cohorts 1 and 3
Time frame: Cohort 2: Day 1, 8, and 15
Time frame: Cohort 2: Day 1, 8, and 15
Sanofi
Industry
An Open-label, Non-randomized, Single Sequence, Two Periods, Four-treatment, Three Parallel Groups Pharmacokinetic Interaction Study of Repeated Oral Doses (Daily or Weekly Regimen) of Rifapentine on ATRIPLA™ (Fixed Dose Combination of Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate) Given to HIV+ Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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