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

Keywords

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