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临床试验/NCT00002423
NCT00002423已完成2 期

A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks

Glaxo Wellcome15 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1999年3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
入组人数
100
试验地点
15

研究概览

简要总结

This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.

详细描述

Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.

研究设计

研究类型
Interventional
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

入选标准

  • You may be eligible for this trial if you:
  • Are HIV-positive.
  • Are 13 years of age or older.
  • Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
  • In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
  • Have the written consent of a parent or legal guardian if you are under age
  • Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
  • Are willing to complete the 48-week study.

排除标准

  • You will not be eligible for this trial if you:
  • Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
  • Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
  • Have had certain types of hepatitis in the past 6 months.
  • Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
  • Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
  • Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.

研究者

发起方
Glaxo Wellcome
申办方类型
Industry

研究点 (15)

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