Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will ...
Detailed Description
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 sa...
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.)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00000897
Last Update
March 2 2011
Active Locations (6)
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1
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
2
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
3
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
4
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215