Safety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093.

TitleSafety and tolerability of depot medroxyprogesterone acetate among HIV-infected women on antiretroviral therapy: ACTG A5093.
Publication TypeJournal Article
Year of Publication2008
AuthorsD Watts H, Park J-G, Cohn SE, Yu S, Hitti J, Stek A, Clax PA, Muderspach L, Lertora JJL
JournalContraception
Volume77
Issue2
Pagination84-90
Date Published2008 Feb
ISSN0010-7824
KeywordsAdult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, CD4 Lymphocyte Count, Contraceptive Agents, Female, Drug Interactions, Female, HIV Infections, Humans, Injections, Intramuscular, Medroxyprogesterone Acetate, Nelfinavir, Nevirapine, Ovulation Inhibition, RNA, Viral, Safety, Viral Load
Abstract

BACKGROUND: Concomitant use of antiretroviral (ARV) and hormonal contraceptives may change the metabolism of each and the resulting safety profiles. We evaluated the safety and tolerability of depot medroxyprogesterone acetate (DMPA) among women on ARV.

STUDY DESIGN: HIV-infected women on selected ARV regimens or no ARV were administered DMPA 150 mg intramuscularly and evaluated for 12 weeks for adverse events, changes in CD4+ count and HIV RNA levels, and ovulation.

RESULTS: Seventy evaluable subjects were included, 16 on nucleoside only or no ARV, 21 on nelfinavir-containing regimens, 17 on efavirenz-containing regimens and 16 on nevirapine-containing regimens. Nine Grade 3 or 4 adverse events occurred in seven subjects; none were judged related to DMPA. The most common findings possibly related to DMPA were abnormal vaginal bleeding (nine, 12.7%), headache (three, 4.2%), abdominal pain, mood changes, insomnia, anorexia and fatigue, each occurring in two (2.9%) subjects. No significant changes in CD4+ count or HIV RNA levels occurred with DMPA. No evidence of ovulation was detected, and no pregnancies occurred.

CONCLUSIONS: The clinical profile associated with DMPA administration in HIV-infected women, most on ARV, appears similar to that seen in HIV-uninfected women. DMPA prevented ovulation and did not affect CD4+ counts or HIV RNA levels. In concert with previously published DMPA/ARV interaction data, these data suggest that DMPA can be used safely by HIV-infected women on the ARV studied.

DOI10.1016/j.contraception.2007.10.002
Alternate JournalContraception
PubMed ID18226670
PubMed Central IDPMC2424313
Grant List5 M01 RR 00044 / RR / NCRR NIH HHS / United States
AI 069434 / AI / NIAID NIH HHS / United States
AI 25859 / AI / NIAID NIH HHS / United States
AI 27644 / AI / NIAID NIH HHS / United States
AI 27658 / AI / NIAID NIH HHS / United States
AI 27673 / AI / NIAID NIH HHS / United States
AI 32782 / AI / NIAID NIH HHS / United States
AI 32783 / AI / NIAID NIH HHS / United States
AI 32913 / AI / NIAID NIH HHS / United States
AI 38858 / AI / NIAID NIH HHS / United States
AI 46370 / AI / NIAID NIH HHS / United States
AI 50410 / AI / NIAID NIH HHS / United States
AI 68363 / AI / NIAID NIH HHS / United States
AI 69423 / AI / NIAID NIH HHS / United States
AI 69451 / AI / NIAID NIH HHS / United States
AI 69470 / AI / NIAID NIH HHS / United States
AI 69501 / AI / NIAID NIH HHS / United States
HD 33612 / HD / NICHD NIH HHS / United States
IU01 AI 3844 / AI / NIAID NIH HHS / United States
M01 RR 00044 / RR / NCRR NIH HHS / United States
M01 RR 000750 / RR / NCRR NIH HHS / United States
M01 RR 05096 / RR / NCRR NIH HHS / United States
M01 RR000044-430733 / RR / NCRR NIH HHS / United States
N01 HD 33345 / HD / NICHD NIH HHS / United States
P30 AI 45008 / AI / NIAID NIH HHS / United States
RR 00046 / RR / NCRR NIH HHS / United States
U01 AI 27658 / AI / NIAID NIH HHS / United States
U01 AI 32783 / AI / NIAID NIH HHS / United States
U01 AI 38855 / AI / NIAID NIH HHS / United States
U01 AI027658-120006 / AI / NIAID NIH HHS / United States
U01 AI027664 / AI / NIAID NIH HHS / United States
U01 AI027664-130006 / AI / NIAID NIH HHS / United States
U01 AI027664-170006 / AI / NIAID NIH HHS / United States
U01 AI038844-020005 / AI / NIAID NIH HHS / United States
U01 AI038844-030006 / AI / NIAID NIH HHS / United States
U01 AI038855 / AI / NIAID NIH HHS / United States
U01 AI038855-04 / AI / NIAID NIH HHS / United States
U01 AI038858 / AI / NIAID NIH HHS / United States
U01 AI038858-020006 / AI / NIAID NIH HHS / United States
U01 AI038858-030006 / AI / NIAID NIH HHS / United States
U01 AI038858-04 / AI / NIAID NIH HHS / United States
Z99 HD999999 / / Intramural NIH HHS / United States