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
The Effect of Oral and Injectable Contraceptives (Norethindrone/Ethinyl Estradiol, Medroxyprogesterone Acetate) and Gender on Plasma and Intracellular Zidovudine Pharmacokinetics
2 other identifiers
interventional
42
1 country
6
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 also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedMarch 2, 2011
March 1, 2011
November 2, 1999
March 1, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Francesca Aweeka
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
October 1, 2005
Last Updated
March 2, 2011
Record last verified: 2011-03