A5338: DMPA in HIV/TB

An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions among Depo-medroxyprogesterone Acetate (DMPA), Rifampicin (RIF), and Efavirenz (EFV) in Women Co-infected with Human Immunodeficiency Virus (HIV) and Tuberculosis (TB)

Treatment Category:  Women

Study Description
This study will examine the use of three drugs together to treat women who have both tuberculosis (TB) and HIV and who do not want to become pregnant. Depot medroxyprogesterone acetate (DMPA, also known as Depo-Provera) is a birth control drug; rifampicin (RIF) is an anti-TB medication; and efavirenz (EFV, also known as Stocrin) is an anti-HIV medication. It is unknown whether treating both HIV and TB using EFV and RIF and also administering DMPA together will affect the amount of DMPA in the blood, and whether it can prevent pregnancy if the level in the blood becomes too low.

Why is this study being done?

  • To find out whether use of RIF together with EFV will affect the ability of DMPA to prevent pregnancy in HIV-infected women of child-bearing age.
  • To establish the best dosing frequency for DMPA in patients who are being treated for TB and HIV.

Who can join?

  • HIV-infected pre-menopausal woman aged between 18 and 46 years.
  • Have TB  
  • Receiving EFV-based ART for at least 4 weeks
  • Receiving RIF and INH-based TB therapy after completing intensive TB treatment
  • Negative pregnancy test
  • Not taking DMPA or other hormonal birth control

What do I need to do in the study?
Participants will be given DMPA 150 mg as an injection in a muscle (usually in the buttock, or backside, or in the upper left arm) as a single dose.  

The participant will also continue taking the required EFV-based ART and RIF-based TB therapy.

The study will last 12 weeks from entry through the final study visit. 

What treatments or drugs are involved with this study?
DMPA will be provided by the study. An optional dose of DMPA will be available at no cost after all week 12 study evaluations are completed. EFV-based ART and RIF will need to be provided by the local provider. 

 

Study Status: