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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

This study has been completed.

Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002205
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Abacavir sulfate
Drug: Amprenavir

MedlinePlus related topics:   AIDS   

Drug Information available for:   Abacavir    Abacavir sulfate    VX 478   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   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

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

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002205

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

Sponsors and Collaborators
Glaxo Wellcome
  More Information


Study ID Numbers:   264H
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002205
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV Protease Inhibitors  
VX 478  
Anti-HIV Agents  
abacavir  

Study placed in the following topic categories:
Virus Diseases
Amprenavir
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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