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

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051844


Locations
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Sponsors and Collaborators
Pfizer
More Information
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00051844    
Other Study ID Numbers: A4311002
First Posted: January 20, 2003    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011
Keywords provided by Pfizer:
HIV
NNRTI Failure
HIV Infections
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Slow Virus Diseases
Capravirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents