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
NCT ID: NCT00000864
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2001-01-31
Brief Summary
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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.
Detailed Description
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This study is divided into 3 sections, as follows: Part 1A is a single-dose study in neonates 0 to 72 hours of age. If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity, the ABC dose is escalated. Part 1B is also a single-dose study in infants 21 to 28 days of age, starting with the dose identified in Part 1A. If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity, the dose is escalated again. Finally, Part 2 is a multi-dose study to examine a dosing regimen for ABC and ZDV for neonates 0 to 72 hours of age. The dosing regimen for ABC is the dose defined in Part 1A for the first 3 weeks (0 to 3 weeks of age) followed by the dose defined in Part 1B for the second 3 weeks (3 to 6 weeks of age). All patients receive 6 weeks of standard ZDV therapy.
\[AS PER AMENDMENT 9/24/97: This study is divided into sections, as follows: Part 1A is a single-dose study in neonates 0 to 48 hours of age. ABC dose escalations are made until a dose is identified that meets toxicity guidelines and demonstrates a minimal target area under the concentration curve (AUC) of 2,000 ng-hr/ml. Part 1B is a similar single-dose study in infants 3 to 7 days of age with escalation as per part 1A. Part 1C is an identical single-dose study in infants 21 to 28 days of age but starting at the dose identified in Part 1B. Part 2 is a multi-dose study to examine a 6-week dosing regimen for ABC and ZDV for infants 0 to 48 hours of age. The dosing regimen for ABC is defined in Part 1A for the first 48 hours of life, the dose defined in Part 1B for Days 3 through 20 of life, and the dose defined in Part 1C for Days 21 through 42 of life.\] \[AS PER AMENDMENT 7/29/98: Enrollment to Parts 1A and 1B will remain open; Part 1A will enroll a minimum of 4 patients as planned, and Part 1B will enroll 3 additional patients.\]
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Abacavir sulfate
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Day
28 Days
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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George Johnson
Role: STUDY_CHAIR
Andrew Wiznia
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Other Identifiers
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11295
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 321
Identifier Type: -
Identifier Source: secondary_id
ACTG 321
Identifier Type: -
Identifier Source: org_study_id