A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Oral contraceptives have been shown to substantially enhance the glucuronidation of several compounds. One study reported enhanced glucuronidation of oxazepam, a compound that is conjugated via the same UDP-glucuronyl transferase isozyme responsible for ADV glucuronidation, suggesting that ZDV metabolism may be altered by concomitant oral contraceptive use. This potential enhancement of ZDV metabolism by oral contraceptives is expected to result in decreased plasma levels of the parent compound which may lead to diminished clinical efficacy in women using these drugs. It remains unclear whe...

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Eligibility criteria

• • Inclusion Criteria
• Men and women may be eligible for this study if they:
• • Are HIV positive.
• Women may be eligible for this study if they:
• • Have regular periods and a normal gynecological exam, (including a Pap smear and mammogram).
• • Enter the study between Days 10 and 18 of the first day of their last period.
• • Are willing to use either the Pill or Depo-Provera as birth control.
• • Have a negative pregnancy test within 14 days prior to study.
• • Exclusion Criteria
• Men and women will not be eligible for this study if they:
• • Cannot take ZDV for any reason.
• • Have cancer.
• • Are taking stavudine.
• Women will not be eligible for this study if they:
• • Cannot take the Pill or Depo-Provera.
• • Are pregnant or nursing.
• • Are receiving nelfinavir and want to enroll in Step 2.
• • Have a history of chronic high blood pressure, thrombophlebitis, and/or pulmonary emboli if participating in Step 2 of the study.
• • (This study has been changed so that women with certain criteria are excluded from participating in Step 2.)