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CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, N.I.H., EXTRAMURAL
RESEARCH SUPPORT, NON-U.S. GOV'T
RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
Pharmacokinetic interactions between depot medroxyprogesterone acetate and combination antiretroviral therapy.
Fertility and Sterility 2008 October
OBJECTIVE: To evaluate the effect of an antiretroviral (ARV) therapy regimen containing zidovudine (AZT), lamivudine (3TC), and efavirenz (EFV) on the pharmacokinetics of depot medroxyprogesterone acetate (DMPA).
DESIGN: Open-label, nonrandomized, clinical trial.
SETTING: University hospital clinic.
PATIENT(S): Thirty HIV-infected women; 15 using ARV therapy (AZT, 3TC, and EFV) and 15 non-users of ARV therapy, followed biweekly for 12 weeks.
INTERVENTION(S): Single injection of DMPA (150 mg IM) for both groups.
MAIN OUTCOME MEASURE(S): Pharmacokinetic parameters of DMPA by liquid chromatography with mass spectrometry, and ovulation by serum P.
RESULT(S): Maximum serum concentrations of DMPA were reached at 14 days after injection. The area under the curve was similar in both groups, as were the minimum concentration, half-life, and clearance. Only 1 woman, not using ARV therapy, ovulated at 11 weeks after DMPA.
CONCLUSION(S): Pharmacokinetics of DMPA were similar in HIV-infected women, regardless of ARV therapy use, suggesting that triple therapy with AZT, 3TC, and EFV is not likely to interfere with the contraceptive effectiveness of DMPA.
DESIGN: Open-label, nonrandomized, clinical trial.
SETTING: University hospital clinic.
PATIENT(S): Thirty HIV-infected women; 15 using ARV therapy (AZT, 3TC, and EFV) and 15 non-users of ARV therapy, followed biweekly for 12 weeks.
INTERVENTION(S): Single injection of DMPA (150 mg IM) for both groups.
MAIN OUTCOME MEASURE(S): Pharmacokinetic parameters of DMPA by liquid chromatography with mass spectrometry, and ovulation by serum P.
RESULT(S): Maximum serum concentrations of DMPA were reached at 14 days after injection. The area under the curve was similar in both groups, as were the minimum concentration, half-life, and clearance. Only 1 woman, not using ARV therapy, ovulated at 11 weeks after DMPA.
CONCLUSION(S): Pharmacokinetics of DMPA were similar in HIV-infected women, regardless of ARV therapy use, suggesting that triple therapy with AZT, 3TC, and EFV is not likely to interfere with the contraceptive effectiveness of DMPA.
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