A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
NCT ID: NCT00000750
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
PHASE3
400 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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Secondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants.
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.
Detailed Description
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Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* CD4 count \>= 2000 cells/mm3 AND \>= 30 percent of total lymphocytes.
* No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted).
* Consent of parent or guardian.
Exclusion Criteria
Patients with the following symptoms and conditions are excluded:
* Serious acute infection requiring parenteral therapy at time of entry.
* One or more serious, proven bacterial infections including any of the following:
* septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria.
* Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile.
Concurrent Medication:
Excluded:
* Any agent with known antiretroviral activity.
* Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.
Prior Medication:
Excluded:
* More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.
Recommended:
* PCP prophylaxis.
* Immunizations according to current recommendations.
1 Day
9 Months
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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E Connor
Role: STUDY_CHAIR
G McSherry
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Metropolitan Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Lincoln Hosp Ctr
The Bronx, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Westchester Hosp
Valhalla, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11157
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 182
Identifier Type: -
Identifier Source: org_study_id