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

• Status: Completed
• Trial end date: 2001-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies.

Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Abacavir; Zidovudine

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.