A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 14
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
详细描述
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
- •CD4+ cell count of at least 300 cells/mm
- •HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
- •CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
- •Compliance with dosing schedule and protocol evaluations.
- •Prior Medication:
- •3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.
- •Inhaled corticosteroids for the treatment of asthma.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
- •Enrollment in other investigational protocols.
- •Concurrent Medication:
- •Cytotoxic chemotherapeutic agents.
- •Nonnucleoside reverse transcriptase inhibitors.
- •Other investigational agents.
- •Concurrent Treatment:
- •Radiation therapy.
- •Prior Medication:
- •Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
- •HIV immunotherapeutic vaccine within 3 months of study entry.
- •Prior Treatment:
- •Radiation therapy within 4 weeks of study entry.