Completed
The Effect of Oral and Injectable Contraceptives (Norethindrone/Ethinyl Estradiol, Medroxyprogesterone Acetate) and Gender on Plasma and Intracellular Zidovudine Pharmacokinetics
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-02
42
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 6 locations
1
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
2
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
3
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Status Unknown
4
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
5
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
6
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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