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Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

NCT ID: NCT00006591

Last Updated: 2005-06-24

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

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

Detailed Description

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HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Conditions

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HIV Infections

Keywords

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Drug Therapy, Combination HIV Protease Inhibitors Ritonavir VX 478 Salvage Therapy Anti-HIV Agents Drug Monitoring Nelfinavir Treatment Experienced

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ritonavir

Intervention Type DRUG

Amprenavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are 18 years of age or older.
* Are HIV-positive.
* Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
* Have had more than 12 weeks of prior anti-HIV drug treatment.
* Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
* Are responsive to Agenerase.
* Are able to follow study requirements.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are intolerant to ritonavir (an anti-HIV drug).
* Have or have had problems with absorption.
* Have liver disease or damage.
* Have pancreatic disease or damage.
* Have taken any protease inhibitor other than nelfinavir.
* Are receiving investigational drugs or devices from another study.
* Are pregnant or breast-feeding.
* Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
* Have a bleeding disorder.
* Have previously been treated with Agenerase.
* Are receiving nonnucleosides.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gathe, Joseph, M.D.

INDIV

Sponsor Role lead

Locations

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Gathe, Joseph, M.D.

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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APV-430

Identifier Type: -

Identifier Source: secondary_id

313A

Identifier Type: -

Identifier Source: org_study_id