NCT00000864

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 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

PregnancyPregnancy Complications, InfectiousHIV-1Drug Therapy, CombinationZidovudineDrug Administration ScheduleDisease Transmission, VerticalReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

Abacavir sulfateDRUG
ZidovudineDRUG

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UAB, Dept. of Ped., Div. of Infectious Diseases

Birmingham, Alabama, 35233, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, 900951752, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Atlanta, Georgia, 30306, United States

Location

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

Chicago, Illinois, 60612, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 021155724, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 277103499, United States

Location

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

Charleston, South Carolina, 294253312, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 009367344, Puerto Rico

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsPregnancy Complications, Infectious

Interventions

abacavirZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • George Johnson

    STUDY CHAIR

  • Andrew Wiznia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

January 1, 2001

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

PR(1)US(12)