PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB
Status:
Completed
Trial end date:
2017-06-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)