CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Depot medroxyprogesterone acetatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02412436
NCT02412436Phase 2Completed

An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among Depot Medroxyprogesterone Acetate (DMPA), Rifampicin (RIF), and Efavirenz (EFV) in Women Co-infected With Human Immunodeficiency Virus (HIV) and Tuberculosis (TB)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Apr 9, 2015·Updated Jul 1, 2019

In Brief

A Phase 2 clinical trial evaluating Depot medroxyprogesterone acetate for HIV-1 Infection and Tuberculosis. Completed, enrolled 62 participants across 5 sites in 4 countries.

Detailed Summary

This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB medication), and isoniazid (INH; an anti-TB medication). The purpose of this study was to find out the best frequency to give depot medroxyprogesterone acetate (DMPA; a hormonal birth control method that is given as a shot every 3 months) in these women. This study also tried to find out if a 150 mg injection of DMPA was effective in preventing ovulation, the process by which the ovaries (the ovaries are part of the female reproductive system) release an egg for fertilization, for 12 weeks in women who are taking EFV and RIF. Another purpose of this study was to find out if it is safe to take RIF, EFV and DMPA at the same time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBotswana, Kenya, South Africa, Zimbabwe

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartNov 3, 2015
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.2 years ago

Interventions

Depot medroxyprogesterone acetatedrug

Depot medroxyprogesterone acetate intramuscular injection