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Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006591
First received: December 1, 2000
Last updated: June 23, 2005
Last verified: December 2004

December 1, 2000
June 23, 2005
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Complete list of historical versions of study NCT00006591 on ClinicalTrials.gov Archive Site
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Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals

The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Ritonavir
  • Drug: Amprenavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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Inclusion Criteria

Patients may be eligible for this study if they:

  • Are 18 years of age or older.
  • Are HIV-positive.
  • Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
  • Have had more than 12 weeks of prior anti-HIV drug treatment.
  • Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
  • Are responsive to Agenerase.
  • Are able to follow study requirements.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are intolerant to ritonavir (an anti-HIV drug).
  • Have or have had problems with absorption.
  • Have liver disease or damage.
  • Have pancreatic disease or damage.
  • Have taken any protease inhibitor other than nelfinavir.
  • Are receiving investigational drugs or devices from another study.
  • Are pregnant or breast-feeding.
  • Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
  • Have a bleeding disorder.
  • Have previously been treated with Agenerase.
  • Are receiving nonnucleosides.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006591
313A, APV-430
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Gathe, Joseph, M.D.
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NIH AIDS Clinical Trials Information Service
December 2004

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