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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Indinavir sulfate
* Drug: Ritonavir
* Drug: Delavirdine mesylate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Ritonavir|nan|
|Drug: Delavirdine mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Salvage Therapy, Anti-HIV Agents, Viral Load, Nelfinavir