NCT00002241Unknown2 期
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 18
研究概览
简要总结
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
详细描述
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be eligible for this study if they:
- •Are HIV-positive.
- •Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
- •Are age 16 or older (consent of a parent or guardian required if under 18).
- •Agree to practice abstinence or use barrier methods of birth control (such as condoms).
- •Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)
排除标准
- •Patients will not be eligible for this study if they:
- •Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
- •Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
- •Have changed their medications in the last 2 weeks.
- •Are allergic to IDV, RTV, d4T, or 3TC.
- •Have used certain medications (see the technical summary for more detail).
- •Are pregnant or breast-feeding.
研究者
研究点 (18)
Loading locations...
相似试验
Unknown
2 期
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV DrugsHIV InfectionsNCT00002451Merck Sharp & Dohme LLC8
Unknown
2 期
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention TreatmentHIV InfectionsNCT00005118Merck Sharp & Dohme LLC100
已完成
不适用
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive PatientsHIV InfectionsNCT00002236Pharmacia and Upjohn32
Unknown
3 期
Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV DrugsHIV InfectionsNCT00006397PPD Development, LP200
已完成
3 期
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected PatientsHIV InfectionsNCT00002406Merck Sharp & Dohme LLC350