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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00052117
First received: January 22, 2003
Last updated: October 5, 2007
Last verified: October 2007
History of Changes

January 22, 2003
October 5, 2007
January 2003
Not Provided
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
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Complete list of historical versions of study NCT00052117 on ClinicalTrials.gov Archive Site
  • 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)
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Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
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

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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: capravirine
  • Drug: Kaletra
  • Drug: 2 NRTIs
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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
300
May 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States,   Argentina,   Brazil,   Canada,   France,   Mexico,   Netherlands,   South Africa,   Spain,   United Kingdom
 
NCT00052117
A4311006
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Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2007

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