PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB

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.

Timeline

Start

2015-11-03

Primary completion

2017-06-15

Completion

2017-06-15

Publications

• Haas DW, Mngqibisa R, Francis J, McIlleron H, Robinson JA, Kendall MA, Baker P, Mawlana S, Badal-Faesen S, Angira F, Omoz-Oarhe A, Samaneka WP, Denti P, Cohn SE; AIDS Clinical Trials Group A5338 Study Team. Pharmacogenetics of interaction between depot medroxyprogesterone acetate and efavirenz, rifampicin, and isoniazid during treatment of HIV and tuberculosis. Pharmacogenet Genomics. 2022 Jan 1;32(1):24-30. doi: 10.1097/FPC.0000000000000448.
• Mngqibisa R, Kendall MA, Dooley K, Wu XS, Firnhaber C, Mcilleron H, Robinson J, Cramer Y, Rosenkranz SL, Roa J, Coughlin K, Mawlana S, Badal-Faesen S, Schnabel D, Omoz-Oarhe A, Samaneka W, Godfrey C, Cohn SE; A5338 Study Team. Pharmacokinetics and Pharmacodynamics of Depot Medroxyprogesterone Acetate in African Women Receiving Treatment for Human Immunodeficiency Virus and Tuberculosis: Potential Concern for Standard Dosing Frequency. Clin Infect Dis. 2020 Jul 27;71(3):517-524. doi: 10.1093/cid/ciz863.

Drugs

Indications