Completed
Phase I Study of Safety, Tolerance, and Pharmacokinetics of Abacavir 1592U89, ABC With Standard Zidovudine ZDV Therapy In Neonates Born to HIV-1 Infected Women
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
60
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
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
Who Can Participate
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.
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