NCT00025727Unknown3 期
A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 330
- 试验地点
- 32
研究概览
简要总结
The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
详细描述
Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.
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
- 13 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:
- •Have a viral load of 1,000 or more copies/ml.
- •Have taken protease inhibitors (PIs).
- •Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
- •Are now taking antiretroviral therapy.
- •Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under
- •Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.
排除标准
- •Patients will not be eligible for this study if they:
- •Have taken APV or LPV for more than 1 week.
- •Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
- •Have taken more than 2 PIs.
- •Are unable to take 2 active RTIs, as specified by the study.
- •Have an active CDC Category C disease.
- •Have certain abnormal laboratory tests.
- •Are pregnant or breast-feeding.
- •Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
- •Have a history of significant kidney or bone disease.
- •Are not able to take drugs by mouth and cannot absorb them.
- •Have had pancreatitis or hepatitis within the previous 6 months.
- •Have a drug allergy or other allergy which might cause a problem during the study.
- •Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
- •Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
- •Have had any HIV vaccine within 3 months before taking the study drug.
- •Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
- •Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
- •Are not able to take the study drugs.
- •Have inadequate kidney function.
研究者
研究点 (32)
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