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

Pfizer300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

HIV Infections

Interventions

capravirineDRUG

KaletraDRUG

2 NRTIsDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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