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A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002423
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999

November 2, 1999
June 23, 2005
March 1999
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Complete list of historical versions of study NCT00002423 on ClinicalTrials.gov Archive Site
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A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Abacavir sulfate
  • Drug: Amprenavir
  • Drug: Nelfinavir mesylate
  • Drug: Lamivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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Inclusion Criteria

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 18.
  • 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.

Exclusion Criteria

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002423
264M, PRO20005
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
December 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP