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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Ritonavir; Drug: Amprenavir

Detailed Description

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Gathe, Joseph, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Gathe, Joseph, M.D.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: December 1, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: December 1, 2004

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Anti-HIV Agents; Treatment Experienced; HIV Protease Inhibitors; Nelfinavir; Ritonavir; VX 478; Salvage Therapy; Drug Monitoring
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Ritonavir; Amprenavir
• Other Study ID Numbers: 313A; APV-430

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No