A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 20
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
详细描述
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
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 an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
- •Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
- •Are at least 18 years old.
- •Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.
排除标准
- •Patients will not be eligible for this study if they:
- •Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
- •Have an opportunistic (HIV-related) infection.
- •Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
- •Have had diarrhea lasting at least 15 days within 30 days prior to screening.
- •Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
- •Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.
- •Are allergic to any of the study medications.
- •Have a tumor other than certain skin or cervical cancers.
- •Are on chemotherapy that cannot be discontinued during the study.
- •Are taking an investigational drug within 30 days prior to screening.
- •Have ever received an HIV vaccine.
- •Are taking certain medications.
- •Abuse drugs or alcohol.
- •Have hemophilia or another blood clotting disorder.
- •Have had an organ transplant.
- •Are pregnant or breast-feeding.