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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Drug: Capravirine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	179 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	August 2002
Actual Study Completion Date :	November 2004

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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
2. 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 :

1. The safety and tolerability of 2 doses of capravirine.
2. The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
3. The relationship of HIV resistance (genotype and phenotype) to virologic response.
4. The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
5. The population pharmacokinetics of capravirine and VIRACEPT
6. The pharmacokinetics of potential drug-drug interactions.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 52 Study Locations

Sponsors and Collaborators

Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00051844 History of Changes
Other Study ID Numbers:	A4311002
First Posted:	January 20, 2003
Last Update Posted:	May 10, 2011
Last Verified:	May 2011

Keywords provided by Pfizer:

HIV; NNRTI Failure; HIV Infections

Additional relevant MeSH terms:

Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; HIV Infections; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases	Reverse Transcriptase Inhibitors; Nelfinavir; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; HIV Protease Inhibitors; Protease Inhibitors; Anti-HIV Agents