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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00051844
First received: January 16, 2003
Last updated: May 9, 2011
Last verified: May 2011

January 16, 2003
May 9, 2011
August 2002
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  • 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.
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Complete list of historical versions of study NCT00051844 on ClinicalTrials.gov Archive Site
  • 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.
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Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
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

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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: Capravirine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
November 2004
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   South Africa,   Spain
 
NCT00051844
A4311002
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Not Provided
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP