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


METHODS
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.
Watts
D Heather
DH
National Institute of Child Health and Human Development, NIH, Bethesda, MD 20892, USA. wattsh@mail.nih.gov
Park
Jeong-Gun
JG
Cohn
Susan E
SE
Yu
Song
S
Hitti
Jane
J
Stek
Alice
A
Clax
Pamela A
PA
Muderspach
Laila
L
Lertora
Juan J L
JJ
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003521:Cyclopropanes; D004347:Drug Interactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects; D019888:Nelfinavir / Q000008:administration & dosage / Q000009:adverse effects; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects; D034445:Ovulation Inhibition / Q000187:drug effects*; D012367:RNA, Viral / Q000097:blood; D012449:Safety; D019562:Viral Load
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003271:Contraceptive Agents, Female; D003521:Cyclopropanes; D012367:RNA, Viral; D019829:Nevirapine; D017258:Medroxyprogesterone Acetate; D019888:Nelfinavir; C098320:efavirenz