Search / Trial NCT00000897

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

Apply for Trial

Trial Information

Current as of May 23, 2024

Completed

Keywords

Drug Interactions Zidovudine Sex Factors Reverse Transcriptase Inhibitors Contraceptives, Oral Progestational Hormones, Synthetic Anti Hiv Agents Viral Load Estrogens

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 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...

Gender

All

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.)

Attachments

readout_NCT00000897_2024-05-23.pdf

4.5 MB

NCT00000897_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

Albany, New York, United States

Chapel Hill, North Carolina, United States

Buffalo, New York, United States

San Francisco, California, United States

Jacksonville, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0