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

NCT ID: NCT00052117

Last Updated: 2007-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-05-31

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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capravirine

Intervention Type DRUG

Kaletra

Intervention Type DRUG

2 NRTIs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Countries

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

Other Identifiers

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A4311006

Identifier Type: -

Identifier Source: org_study_id