A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 22
研究概览
简要总结
To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration.
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
详细描述
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks.
PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV-1 seropositivity.
- •CD4 count >= 550 cells/mm
- •Asymptomatic disease.
- •No prior antiretroviral therapy.
- •Consent of parent or guardian if less than 18 years old.
- •PER AMENDMENT 6/18/96:
- •Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Medical condition that precludes study compliance.
- •Concurrent Medication:
- •Antiretrovirals other than study drugs.
- •Biologic response modifiers including erythropoietin and G-CSF.
- •Systemic corticosteroids.
- •Systemic cytotoxic chemotherapy.
- •Intravenous pentamidine.
- •Concurrent Treatment:
- •Systemic radiation therapy.
- •Patients with the following prior conditions are excluded:
- •History of grade 2 or worse peripheral neuropathy.
- •History of pancreatitis or factors predisposing to pancreatitis.
- •Prior Medication:
- •Prior antiretrovirals.
- •Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry.
- •Chronic alcoholism.