Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

Study Overview
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Brief Summary
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This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

Official Title
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A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Capravirine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years old HIV RNA level >1000 copies/mL at screening CD4 >50 cells/uL at screening Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L) Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal) Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal) Exclusion Criteria: Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept Women who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capravirine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks |  |  | 
| when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of 2 doses of capravirine. |  |  | 
| The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics |  |  | 
| The relationship of HIV resistance (genotype and phenotype) to virologic response. |  |  | 
| The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts |  |  | 
| The population pharmacokinetics of capravirine and VIRACEPT |  |  | 
| The pharmacokinetics of potential drug-drug interactions. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, NNRTI Failure, HIV Infections