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

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ClinicalTrials.gov Identifier: NCT00006591
Recruitment Status : Unknown
Verified December 2004 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ritonavir Drug: Amprenavir Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006591


Locations
United States, Texas
Gathe, Joseph, M.D.
Houston, Texas, United States, 77004
Sponsors and Collaborators
Gathe, Joseph, M.D.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00006591     History of Changes
Other Study ID Numbers: 313A
APV-430
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2004

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
VX 478
Salvage Therapy
 Anti-HIV Agents
Drug Monitoring
Nelfinavir
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Amprenavir
HIV Protease Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents