Back to resultsFour-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
capravirine
Kaletra
2 NRTIs
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
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
Sites / Locations
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00052117
Brief Title
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
capravirine
Intervention Type
Drug
Intervention Name(s)
Kaletra
Intervention Type
Drug
Intervention Name(s)
2 NRTIs
Primary Outcome Measure Information:
Title
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
Secondary Outcome Measure Information:
Title
the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome
Title
the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling
Title
the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
We'll reach out to this number within 24 hrs