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
Official 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
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 13 locations
1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
Status Unknown
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
Status Unknown
4
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
Status Unknown
5
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
6
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
Status Unknown
7
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States, 60612
Status Unknown
8
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 021155724
Status Unknown
9
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
Status Unknown
10
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States, 10457
Status Unknown
11
DUMC Ped. CRS
Durham, North Carolina, United States, 277103499
Status Unknown
12
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 294253312
Status Unknown
13
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 009367344
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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