PER-076-00已完成未知
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 with Efavirenz; Each in Combination with Fixed Dose Zidovudine-Lamivudine
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2000年1月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Qualifying plasma HIV RNA > 2,000 c/mL and a CD4 cell count of 3 3 > 100 cells/mm (or > 75 cells/mm with no prior history of any AIDS-defining diagnoses) obtained within 2 weeks prior to randomization;
- •>16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate);
- •Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted;
- •Subjects must be able to provide written informed consent;
- •Subjects should be available for follow-up for a period of at least 52 weeks;
- •Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
- •o serum creatinine < 1.5 times the upper limit of normal,
- •o total serum lipase < 1.4 times the upper limit of normal,
- •o liver enzymes (AST, ALT) < 3 times the upper limit of normal,
- •o total serum bilirubin < 1.5 times the upper limit of normal.
排除标准
- •Prior antiretroviral therapy (< 30 days of nucleoside and/or < 7 days of NNRTI or protease inhibitor therapies will be permitted, provided that the last dose(s) was/were >30 days prior to screening);
- •Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
- •Suspected primary (acute) HIV infection;
- •Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are < 3 times the upper limit of normal;
- •Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment or therapy with methadone or ribavirin/interferons;
- •Active alcohol or substance abuse sufficient, in the Investigator´s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
- •Intractable diarrhea (> 6 loose stools/day for at least 7 consecutive days) within
- •30 days prior to study entry;
- •Pregnancy or breast-feeding;
- •History of hemophilia;
- •History or signs and symptoms of bilateral peripheral neuropathy > Grade 2 at the time of screening;
- •Inability to tolerate oral medication;
- •Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.
研究者
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