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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Contraceptive Agents; Medroxyprogesterone Acetate; Zidovudine

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.)