A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 42
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Day 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.