Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
1-28 years
Phase:
PHASE1
Brief 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 zidov...
Detailed Description
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 potentia...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2001
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000864
End Date
January 1 2001
Last Update
October 28 2021
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
4
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States