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Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir

This study has been terminated.

Sponsored by: Agouron Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00006326
  Purpose

The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective in patients who have failed previous anti-HIV treatments using nelfinavir (NFV).


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Ritonavir
Drug: Delavirdine mesylate

MedlinePlus related topics:   AIDS    AIDS Medicines   

ChemIDplus related topics:   Indinavir    Indinavir Sulfate    Delavirdine mesylate    Delavirdine    Nelfinavir    Nelfinavir Mesylate    Ritonavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   A Randomized, Open-Label Study to Evaluate 3 Salvage Regimens in HIV-Infected Subjects Experiencing Virologic Failure on an Initial HAART Regimen Containing Nelfinavir

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

Estimated Enrollment:   60
Study Start Date:   August 2000

Detailed Description:

Patients receive 1 of 3 salvage regimens. Treatments A and B include delavirdine, 1 of 2 doses of indinavir, and 2 nucleoside reverse transcriptase inhibitors (NRTIs) to which the patient has not been exposed. Treatment C includes ritonavir, indinavir, and 2 NRTIs to which the patient has not been exposed. When virologic failure is first observed, the patient must return in 2 weeks for confirmation of failure and start the salvage regimen within 1 month of the first assay in which failure was observed. Patients who have less than 400 copies/ml HIV RNA after 16 weeks of therapy are considered responders and continue on the study. Those who have more than 400 copies/ml after 16 weeks of therapy are considered nonresponders and should be discontinued from the study. In addition, patients who respond and subsequently rebound with a viral load 0.5 log above the nadir and greater than 400 copies/ml on 2 consecutive assays at least 2 weeks apart are considered treatment failures and should be discontinued from the study. Patients have regular physical exams, as well as virologic, immunologic, and pharmacokinetic assessments.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Had a viral load of less than 400 copies/ml, followed by an increase in viral load while taking an anti-HIV drug combination including NFV (treatment failure).
  • Can start the study treatment within 1 month of treatment failure.
  • Have a viral load of less than 30,000 copies/ml when they enter the study.
  • Have not taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) other than NFV.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006326

Locations
United States, California
Susan Conner    
      San Diego, California, United States, 92121

Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information


Study ID Numbers:   228H, AG1343-1133, 1133
First Received:   October 2, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00006326
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
HIV Protease Inhibitors  
Ritonavir  
Indinavir  
Delavirdine  
Reverse Transcriptase Inhibitors
Salvage Therapy
Anti-HIV Agents
Viral Load
Nelfinavir

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Indinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Delavirdine
Nelfinavir
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on October 10, 2008




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