Depo-medroxyprogesterone in women on antiretroviral therapy: effective contraception and lack of clinically significant interactions.

TitleDepo-medroxyprogesterone in women on antiretroviral therapy: effective contraception and lack of clinically significant interactions.
Publication TypeJournal Article
Year of Publication2007
AuthorsCohn SE, Park J-G, Watts DH, Stek A, Hitti J, Clax PA, Yu S, Lertora JJL
Corporate AuthorsACTG A5093 Protocol Team
JournalClin Pharmacol Ther
Volume81
Issue2
Pagination222-7
Date Published2007 Feb
ISSN0009-9236
KeywordsAdult, Antiretroviral Therapy, Highly Active, Area Under Curve, Benzoxazines, CD4 Lymphocyte Count, Chromatography, Liquid, Drug Administration Schedule, Drug Interactions, Female, Half-Life, HIV Infections, HIV Protease Inhibitors, Humans, Injections, Medroxyprogesterone Acetate, Middle Aged, Nelfinavir, Nevirapine, Ovulation Inhibition, Oxazines, Progesterone, Reverse Transcriptase Inhibitors, RNA, Viral, Time Factors
Abstract

We conducted an open-label, steady-state pharmacokinetic (PK) study of drug interactions among HIV-infected women treated with depo-medroxyprogesterone acetate (DMPA) while on nucleoside analogues plus nelfinavir (N=21), efavirenz (N=17), or nevirapine (N=16); or nucleosides only or no antiretroviral therapy as a control group (N=16). PK parameters were estimated using non-compartmental analysis, with between-group comparisons of medroxyprogesterone acetate (MPA) PKs and within-subject comparisons of ARV PKs before and 4 weeks after DMPA dosing. Plasma progesterone levels were measured at baseline and at 2, 4, 6, 8, 10, and 12 weeks after DMPA dosing. There were no significant changes in MPA area under the concentration curve, peak or trough concentrations, or apparent clearance in the nelfinavir, efavirenz, or nevirapine groups compared to the control group. Minor changes in nelfinavir and nevirapine drug exposure were seen after DMPA, but were not considered clinically significant. Suppression of ovulation was maintained.

DOI10.1038/sj.clpt.6100040
Alternate JournalClin. Pharmacol. Ther.
PubMed ID17192768
Grant List5M01 RR00044 / RR / NCRR NIH HHS / United States
AI27664 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
IU01AI3844 / AI / NIAID NIH HHS / United States
M01 RR05096 / RR / NCRR NIH HHS / United States
N01-HD-3-3345 / HD / NICHD NIH HHS / United States
U01 AI38855 / AI / NIAID NIH HHS / United States
UO1 AI27658 / AI / NIAID NIH HHS / United States