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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Amprenavir
Sponsored by
Gathe, Joseph, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gathe, Joseph, M.D.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 1, 2000
Last Updated
June 23, 2005
Sponsor
Gathe, Joseph, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00006591
Brief Title
Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
Official Title
The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gathe, Joseph, M.D.

4. Oversight

5. 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.
Detailed Description
HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, VX 478, Salvage Therapy, Anti-HIV Agents, Drug Monitoring, Nelfinavir, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Amprenavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

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

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