Search / Trial NCT00000878

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

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

Trial Information

Current as of December 06, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Stavudine Lamivudine Disease Transmission, Vertical Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

ClinConnect Summary

New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Ph...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Women may be eligible for this study if they:
  • Are HIV-positive.
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Are unable to or refuse to take ZDV or the woman's doctor says that she should take d4T.
  • Are 14 to 34 weeks pregnant.
  • Exclusion Criteria
  • Women will not be eligible for this study if they:
  • Have a history of peripheral neuropathy.
  • Have an active opportunistic infection and/or serious bacterial infection within 14 days of study entry.
  • Have severe diarrhea.
  • Are allergic to d4T or 3TC.
  • Use illicit drugs or abuse alcohol.
  • Are taking anti-HIV drugs other than study medications.
  • Are planning to breast-feed.
  • Are having a problem pregnancy (baby is not developing correctly or will not survive birth) or have had pregnancy complications in the past.
  • * Babies will not be eligible for this study if they:
  • Are unable to take medications by mouth for more than 72 hours.
  • Have severe birth defects or other life-threatening conditions.
  • Are underweight (less than 2 kg).

Trial Officials

Nancy Wade

Study Chair

Sandra Burchett

Study Chair

Salih Yasin

Study Chair

Jash Unadkat

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

Seattle, Washington, United States

Los Angeles, California, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Albany, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Memphis, Tennessee, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Memphis, Tennessee, United States

Jacksonville, Florida, United States

Boston, Massachusetts, United States

Philadelphia, Pennsylvania, United States

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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