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

This study has been terminated.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006326
First received: October 2, 2000
Last updated: June 23, 2005
Last verified: July 2002

October 2, 2000
June 23, 2005
August 2000
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Complete list of historical versions of study NCT00006326 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir
A Randomized, Open-Label Study to Evaluate 3 Salvage Regimens in HIV-Infected Subjects Experiencing Virologic Failure on an Initial HAART Regimen Containing Nelfinavir

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).

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.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Ritonavir
  • Drug: Delavirdine mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
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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.
Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006326
228H, AG1343-1133, 1133
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Agouron Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP