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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Kaletra; Drug: capravirine; Drug: 2 NRTIs

• Study Type: Interventional
• Enrollment: 300
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: January 22, 2003
• First Submitted That Met QC Criteria: January 22, 2003
• First Posted (Estimate): January 23, 2003

Study Record Updates

• Last Update Posted (Estimate): October 10, 2007
• Last Update Submitted That Met QC Criteria: October 5, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Capravirine
• Other Study ID Numbers: A4311006