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

Sponsor

Gathe, Joseph, M.D. (Other)

Overall Status

Unknown status

CT.gov ID

NCT00006591

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Ritonavir Drug: Amprenavir	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.