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NCT00000750 Clinical Trial

A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

HIV Infections Clinical Trial

Official title:
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000750
Other study ID # ACTG 182
Secondary ID 11157
Status Completed
Phase Phase 3
First received
Last updated
Est. completion date September 1996

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population. 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.

Description:

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date September 1996
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 9 Months
Eligibility Inclusion Criteria Patients must have: - 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 Co-existing Condition: 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zidovudine

Locations
Country Name City State
Puerto Rico San Juan City Hosp San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham Schl of Med / Pediatrics Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Albert Einstein College of Medicine Bronx New York
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Lincoln Hosp Ctr Bronx 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 Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Columbus Children's Hosp Columbus Ohio
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Denver Denver Colorado
United States Kaiser Permanente / UCLA Med Ctr Downey California
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of Connecticut / Farmington Farmington Connecticut
United States North Shore Univ Hosp Great Neck New York
United States Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States UCLA Med Ctr / Pediatric Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Yale Univ Med School New Haven Connecticut
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Harlem Hosp Ctr New York New York
United States Metropolitan Hosp Ctr New York New York
United States Mount Sinai Med Ctr / Pediatrics New York New York
United States Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Univ of Rochester Medical Center Rochester New York
United States San Francisco Gen Hosp San Francisco California
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States Westchester Hosp Valhalla New York
United States Children's Hosp of Washington DC Washington District of Columbia
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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