Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01690403
Brief Summary:
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
Detailed Description:
* Screening to admission: up to 21 days
* Admission to the end of the follow-up: up to 41 days
* Period 1: Treatment period of 15 days with ATRIPLA™ (background therapy). Patients should receive the same regimen and dose of ATRIPLA™ during the all study screening and period 1.
* Period 2: Treatment over a period of 21 days in co-administration with rifapentine.
* Follow up: 3 to 5 days after the last rifapentine administration.
Study:
NCT01690403
Study Brief:
Protocol Section:
NCT01690403