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Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: January 22, 2003
Last updated: October 5, 2007
Last verified: October 2007
This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.

Condition Intervention Phase
HIV Infections
Drug: capravirine
Drug: Kaletra
Drug: 2 NRTIs
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs

Secondary Outcome Measures:
  • the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome
  • the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling
  • the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications
  • changes in subject-reported health status and HIV symptoms using the Medical Outcomes Study - HIV Health Survey (MOS-HIV) and the Symptoms Distress Module (National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group)

Estimated Enrollment: 300
Study Start Date: January 2003
Estimated Study Completion Date: May 2005

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

Inclusion Criteria:

  • HIV-infected male or female at least 18 years of age
  • HIV RNA level >1000 copies/mL at screening
  • Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
  • Adequate renal function
  • Adequate hematological function
  • Adequate liver function

Exclusion Criteria:

  • Women who are pregnant or lactating
  • No previous experience with Kaletra
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00052117

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00052117     History of Changes
Other Study ID Numbers: A4311006 
Study First Received: January 22, 2003
Last Updated: October 5, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
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
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on October 21, 2016