CompletedNCT01690403Updated Feb 27, 2015

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

A Phase 1 interventional study of rifapentine (M000473) and EFZ EMT TDF in Tuberculosis, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-02-27.

Sponsored by Sanofi · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Tuberculosis

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Tuberculosis 1,417

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 25 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

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Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

HIV+ male and female patients receiving ATRIPLA™ aged 18 to 55 years old with a CD4 count cells of at least 350

Exclusion criteria

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological (patients with porphyria), neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness other than HIV disease.
Active or latent tuberculosis infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

Experimental
cohort 1
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).
Drug: rifapentine (M000473) · Drug: EFZ EMT TDF
Experimental
cohort 2
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).
Drug: rifapentine (M000473) · Drug: EFZ EMT TDF
Experimental
cohort 3 (optional)
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).
Drug: rifapentine (M000473) · Drug: EFZ EMT TDF

Interventions

Drugrifapentine (M000473)
Pharmaceutical form:tablet Route of administration: oral
DrugEFZ EMT TDF
Pharmaceutical form:tablet Route of administration: oral
Also known as: ATRIPLA™

What researchers measure

Primary outcomes

To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
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

Secondary outcomes

To determine PK parameters t1/2z, tmax for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
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
To determine PK parameters tlag, CL/F for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
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
To determine PK parameter for AUC0-10 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
Time frame: Day -2 and Day 1 for cohorts 1 and 3
To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)
Time frame: Cohort 2: Day 1, 8, and 15
To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)
Time frame: Cohort 2: Day 1, 8, and 15

Study locations

1 site

Investigational Site Number 840001
Buffalo, New York 14202, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01690403
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Sep 21, 2012
Start date: Dec 2012
Primary completion: Mar 2014
Completion: Mar 2014
Last update: Feb 27, 2015

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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