NCT00005118Unknown2 期
A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 40
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
详细描述
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
研究设计
- 研究类型
- Interventional
- 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 may be eligible for this study if they:
- •Are HIV-positive.
- •Are 18 years of age or older.
- •Have a CD4 cell count of at least 50 cells/mm
- •Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
- •Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
- •Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.
- •Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.
- •Are naive to at least one of the selected NRTIs.
排除标准
- 未提供
研究者
研究点 (40)
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
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice DailyHIV InfectionsNCT00002241Merck Sharp & Dohme LLC80
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 Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TCHIV InfectionsNCT00002208Merck Sharp & Dohme LLC400
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