Trials
Search / Trial NCT00000864

A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women

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

Trial Information

Current as of January 15, 2025

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Hiv 1 Drug Therapy, Combination Zidovudine Drug Administration Schedule Disease Transmission, Vertical Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

The rationale for investigation of this agent is to define the safety and pharmacokinetics in young infants to allow for investigation of the efficacy of this agent in combination with ZDV as potential early therapy in newborn and young infants. The rationale for early aggressive therapy is that this may be the best chance to significantly reduce the long-term progression and subsequent impact of HIV-1 infection in vertically infected infants. Early ablation or enhanced suppression of HIV-1 replication may significantly reduce total viral load and may allow maturation, preservation, or reco...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Infants may be eligible for this study if they:
  • Are between birth and 48 hours of age, between 3 and 7 days of age, or between 21 and 28 days of age.
  • Have no serious infections requiring treatment during the study period.
  • Are receiving ZDV therapy.
  • Can tolerate oral feeding.
  • Are born to HIV-positive mothers whose pregnancy lasted at least 37 weeks.
  • Exclusion Criteria
  • Infants will not be eligible for this study if they:
  • Have a major congenital abnormality.
  • Have a serious laboratory or clinical toxicity at time of study entry.
  • Previously enrolled in Part 1 of this study.
  • Are unable to be followed for the duration of this study.

Trial Officials

George Johnson

Study Chair

Andrew Wiznia

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

San Diego, California, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Bronx, New York, United States

Durham, North Carolina, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

Jacksonville, Florida, United States

Syracuse, New York, United States

Charleston, South Carolina, United States

Birmingham, Alabama, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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