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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00052117
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-01-22
• Study First Submitted QC: 2003-01-22
• Study First Posted: 2003-01-23
• Study Completion: 2005-05
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-05
• Last Update Posted: 2007-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

• Women who are pregnant or lactating
• No previous experience with Kaletra

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs

Secondary Outcome Measures

Name	Time	Method
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)