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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051844
• Other study ID #: A4311002
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2003
• Last updated: May 9, 2011
• Start date: August 2002
• Est. completion date: November 2004

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Capravirine

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Lyon	Cedex 3
France	Pfizer Investigational Site	Lyon	Cedex 02
France	Pfizer Investigational Site	Nantes
France	Pfizer Investigational Site	Paris	Cedex 10
Germany	Pfizer Investigational Site	Ulm	Bavaria
Italy	Pfizer Investigational Site	Brescia
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Roma
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Pietermaritzburg
South Africa	Pfizer Investigational Site	Port Elizabeth
South Africa	Pfizer Investigational Site	Pretoria North
South Africa	Pfizer Investigational Site	Soweto
Spain	Pfizer Investigational Site	Baracaldo	Bilbao, Vizcaya
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Bilbao	Vizcaya
Spain	Pfizer Investigational Site	Cordoba
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Galveston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntersville	North Carolina
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jonesboro	Georgia
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Safety Harbor	Florida
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tucker	Georgia
United States	Pfizer Investigational Site	West Hollywood	California
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  South Africa,  Spain, 

Outcome

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