A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 400
- Locations
- 42
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 1 Day to 9 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Any agent with known antiretroviral activity.
- •Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.
- •Prior Medication:
- •More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.
- •Recommended:
- •PCP prophylaxis.
- •Immunizations according to current recommendations.