An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen

To assess the safety, tolerance, and efficacy of amprenavir (APV) plus abacavir (ABC) in patients who have previously failed antiretroviral treatment containing a protease inhibitor (PI). To provide open-label, pre-approval access to APV for adults and adolescents with HIV-1 infection and limited treatment options.

This study is being conducted to provide open-label APV to patients in danger of HIV disease progression, as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in combatting HIV progression and may help those in need, prior to regulatory approval.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Abacavir sulfate; Drug: Amprenavir

Detailed Description

This study is being conducted to provide open-label APV to patients in danger of HIV disease progression, as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies. Despite unapproved status, APV may prove highly efficacious in combatting HIV progression and may help those in need, prior to regulatory approval.

Patients are stratified into one of the following treatment options:

Non-nucleoside reverse transcriptase inhibitor (NNRTI)-naive:

Option 1- APV / ABC / PI / NNRTI / +nucleoside reverse transcriptase inhibitor(s) (NRTI) Option 2- APV / ABC / NNRTI / NRTI(s)

NNRTI-Experienced Patients:

Option 1- APV / ABC / PI / +NRTI(s) Option 2- APV / ABC / +NRTI(s) To assess clinical efficacy, lab values (i.e., hematology, serum chemistry, plasma HIV-1 viral load determination and CD4+ cell count measurements) are collected at pre-entry and every 12 weeks thereafter.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 277093398
      • Glaxo Wellcome Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Hepatic failure with elevated ALT and AST values.
• Malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or render the patient unable to take oral medication.
• Renal failure requiring dialysis.

Concurrent Medication:

Excluded:

Patients currently participating in, or who would qualify for or have access to, an enrolling study of APV (ACTG 398 and ACTG 400).

Patients with the following prior conditions are excluded:

• Patients suffering from serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which, in the opinion of the investigator, would compromise the safety of the patient.
• History of clinically relevant pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

• Previous treatment with more than one HIV protease inhibitor.
• ABC use for greater than 8 weeks prior to enrollment into this study.

Risk Behavior:

Excluded:

Patients with current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the patient's ability to comply with the requirements of the study.

Patients have:

• HIV-1 infection.
• CD4+ cell count less than or equal to 400 cells/mm3 and plasma HIV-1 RNA greater than or equal to 10,000 copies/ml at the first pre-entry assessment.
• Evidence of failure on an antiretroviral treatment regimen containing a protease inhibitor.
• Clinical evidence of failure in their current regimen and require antiretroviral therapy, and need APV plus ABC to induce viral load suppression.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Glaxo Wellcome

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• 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: April 1, 1999

More Information

Terms related to this study

• Keywords: Anti-HIV Agents; HIV Protease Inhibitors; VX 478; abacavir
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Anti-Bacterial Agents; HIV Protease Inhibitors; Viral Protease Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Abacavir; Amprenavir
• Other Study ID Numbers: 264H