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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006591
• Other study ID #: 313A
• Secondary ID: APV-430
• Status: Active, not recruiting
• Phase: N/A
• First received: December 1, 2000
• Last updated: June 23, 2005

Study information

• Verified date: December 2004
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ritonavir

• Amprenavir

Locations

Country	Name	City	State
United States	Gathe, Joseph, M.D.	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gathe, Joseph, M.D.

Country where clinical trial is conducted

United States,