A Master Protocol to Evaluate the Safety and Efficacy of Multi-Drug Combination Antiretroviral Therapy for the Treatment of HIV Infection: Retrovir/HIVID/Nevirapine and Retrovir/HIVID/Invirase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Parexel
- 入组人数
- 225
- 试验地点
- 2
研究概览
简要总结
To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ).
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
详细描述
Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
Patients are randomized to receive AZT/ddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks. Patients are followed at weeks 2 and 4 and every 4 weeks thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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
- •Concurrent Medication:
- •Encouraged:
- •PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study.
- •Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
- •Acyclovir for 21 days or less for acute treatment.
- •Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively.
- •Patients must have:
- •HIV infection.
- •CD4 count 200 - 500 cells/mm
- •No prior antiretroviral therapy.
- •Life expectancy of at least 48 weeks.
- •Consent of parent or guardian if less than 18 years of age.
- •Participating centers are encouraged to enroll female patients.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Any grade 3 or greater toxicity.
- •Symptoms of peripheral neuropathy.
- •Malabsorption or severe chronic diarrhea.
- •Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort.
- •Concurrent Medication:
- •Excluded during the first 28 days of nevirapine administration:
- •Augmentin and other antibiotics containing clavulanic acid.
- •Excluded at any time:
- •Dicumarol, warfarin, and other anticoagulant medications.
- •Tolbutamide.
- •Cimetidine.
- •Erythromycin.
- •Patients with the following prior conditions are excluded:
- •History of acute or chronic pancreatitis.
- •History of grade 2 or worse peripheral neuropathy from any cause.
- •Prior Medication:
- •Any prior antiretroviral therapy.
- •Excluded within 4 weeks prior to study entry:
- •Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon.
- •Immunotherapeutic vaccines.
- •Cytotoxic chemotherapy.
- •Erythromycin.
- •Dicumarol, Coumadin / warfarin, and other anticoagulant medications.
- •Phenobarbital.
- •Amoxicillin / clavulanate.
- •Ticarcillin / clavulanate.
- •Tolbutamide.
- •Erythromycin.
- •Cimetidine.
- •Prior Treatment:
- •Excluded within 4 weeks prior to study entry:
- •Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.