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

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ClinicalTrials.gov Identifier: NCT00052117

Recruitment Status : Completed

First Posted : January 23, 2003

Last Update Posted : October 10, 2007

Sponsor:

Information provided by:

Pfizer

Tracking Information

First Submitted Date ^ICMJE

January 22, 2003

First Posted Date ^ICMJE

January 23, 2003

Last Update Posted Date

October 10, 2007

Study Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00052117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: capravirine
Drug: Kaletra
Drug: 2 NRTIs

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Original Enrollment ^ICMJE

Same as current

Study Completion Date

May 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Argentina, Brazil, Canada, France, Mexico, Netherlands, South Africa, Spain, United Kingdom, United States

Administrative Information

NCT Number ^ICMJE

NCT00052117

Other Study ID Numbers ^ICMJE

A4311006

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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