A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00000750
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, 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
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Connecticut / Farmington
🇺🇸Farmington, Connecticut, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, 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
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Lincoln Hosp Ctr
🇺🇸Bronx, New York, United States
King's County Hosp Ctr / Pediatrics
🇺🇸Brooklyn, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
🇺🇸Buffalo, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Kaiser Permanente / UCLA Med Ctr
🇺🇸Downey, California, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
🇺🇸Birmingham, Alabama, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States