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

Pfizer0 sites300 target enrollmentJanuary 2003

ConditionsHIV Infections

Drugscapravirine Kaletra 2 NRTIs

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Pfizer
Enrollment: 300
Primary Endpoint: To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

May 2005

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

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

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)