Search / Trial NCT00000944

A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Lamivudine Indinavir Disease Transmission, Vertical Anti Hiv Agents

Description

Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants, new, more effective strategies are needed. An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV, may have high viral loads, or may have previously transmitted HIV to an infant while on ZDV monotherapy. The initiation of triple combination therapy, including a protease inhibitor indinavir, during gestation may be the most effective in reducing maternal virus load prior to delivery, thereby p...

Gender

Female

Eligibility criteria

  • Inclusion Criteria
  • Women may be eligible for this study if they:
  • Are HIV-positive.
  • Have been pregnant for 14-28 weeks (are in your 1st or 2nd trimester).
  • Have a normal ultrasound exam when they are screened for the study.
  • Are able to drink 6 glasses of water a day throughout the study.
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Exclusion Criteria
  • Women will not be eligible for this study if they:
  • Cannot take 3TC or ZDV.
  • Have an active opportunistic (HIV-associated) or bacterial infection at study entry.
  • Have chronic diarrhea.
  • Have epilepsy or cancer.
  • Are pregnant with more than 2 children (triplets, etc.)
  • Have risk factors for premature birth, or other problems with their pregnancy.
  • Have any immediate life-threatening illness.
  • Have severe anemia or other illness for which they require blood products.
  • Have a history of chronic liver or kidney disease.
  • Plan to breast-feed.

Attachments

readout_NCT00000944_2024-03-05.pdf

4.5 MB

NCT00000944_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

Boston, Massachusetts, United States

San Francisco, California, United States

Bronx, New York, United States

Bronx, New York, 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
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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?

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