MedTrace Logo

PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB

NCT02412436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-07-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Depot medroxyprogesterone acetate

Depot medroxyprogesterone acetate intramuscular injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Rosie Mngqibisa, MBChB, MPH · Durban Adult HIV CRS

  • Susan E. Cohn, MD, MPH · Northwestern University

  • Jennifer Robinson, MD, MPH · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-03
Primary Completion
2017-06-15
Completion
2017-06-15

Countries

  • Botswana
  • Kenya
  • South Africa
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412436 on ClinicalTrials.gov