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

• ClinicalTrials.gov Identifier: NCT00051844
• Recruitment Status: Completed
• First Posted: January 20, 2003
• Last Update Posted: May 10, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: January 16, 2003
• First Posted Date: January 20, 2003
• Last Update Posted Date: May 10, 2011
• Study Start Date: August 2002
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: October 5, 2007)

• 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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 5, 2007)

• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Human Immunodeficiency Virus
• Intervention: Drug: Capravirine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2011): 179
• Original Enrollment (submitted: June 23, 2005): 150
• Actual Study Completion Date: November 2004
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, South Africa, Spain, United States

Administrative Information

• NCT Number: NCT00051844
• Other Study ID Numbers: A4311002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pfizer
• Verification Date: May 2011