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
  Purpose

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 Intervention
HIV Infections
Drug: Ritonavir
Drug: Amprenavir

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006591

Locations
United States, Texas
Gathe, Joseph, M.D.
Houston, Texas, United States, 77004
Sponsors and Collaborators
Gathe, Joseph, M.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006591     History of Changes
Other Study ID Numbers: 313A, APV-430
Study First Received: December 1, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Ritonavir
Amprenavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on July 23, 2014