NCT00004584已完成2 期
Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
Bristol-Myers Squibb38 个研究点 分布在 5 个国家开始时间: 1999年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 38
研究概览
简要总结
The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.
详细描述
This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.
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.
- •Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
- •Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
- •Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
- •Will most likely respond well to the study drugs, as shown by the results of a lab test.
- •Are at least 18 years old.
- •Agree to use effective barrier methods of birth control (such as condoms).
- •Are available for follow-up for at least 48 weeks.
排除标准
- •Patients will not be eligible for this study if they:
- •Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
- •Have only recently become HIV positive.
- •Abuse alcohol or drugs.
- •Have severe diarrhea within 30 days of study entry.
- •Have hemophilia.
- •Have a history of pancreatitis.
- •Have hepatitis within 30 days of study entry.
- •Have peripheral neuropathy (a painful condition affecting the nervous system).
- •Are unable to take medications by mouth.
- •Are pregnant or breast-feeding.
研究者
研究点 (38)
Loading locations...
相似试验
已完成
1 期
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNAHIV InfectionsNCT03181789National Institute of Allergy and Infectious Diseases (NIAID)56
已完成
1 期
Evaluating Heterologous-Insert Prime-Boost HIV Vaccine Regimens in HIV-Uninfected AdultsHIV InfectionsNCT01095224National Institute of Allergy and Infectious Diseases (NIAID)180
已完成
1 期
Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected AdultsHIV InfectionsNCT00115960National Institute of Allergy and Infectious Diseases (NIAID)120
已完成
1 期
CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV PatientsHIV-1 InfectionsNCT01013415University of Pennsylvania17
Unknown
1 期
Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected AdultsHIV InfectionsNCT00061243National Institute of Allergy and Infectious Diseases (NIAID)36