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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000864

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2001-01-01

Last updated by the study team

2021-10-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. — Chicago, Illinois, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases — Charleston, South Carolina, United States
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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