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Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2004 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Gathe, Joseph, M.D.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006591
First received: December 1, 2000
Last updated: June 23, 2005
Last verified: December 2004
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Purpose
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 | Intervention |
|---|---|
| HIV Infections | Drug: Ritonavir Drug: Amprenavir |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006591
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006591
Locations
| United States, Texas | |
| Gathe, Joseph, M.D. | |
| Houston, Texas, United States, 77004 | |
Sponsors and Collaborators
Gathe, Joseph, M.D.
More Information
| ClinicalTrials.gov Identifier: | NCT00006591 History of Changes |
| Other Study ID Numbers: |
313A APV-430 |
| Study First Received: | December 1, 2000 |
| Last Updated: | June 23, 2005 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination HIV Protease Inhibitors Ritonavir VX 478 Salvage Therapy |
Anti-HIV Agents Drug Monitoring Nelfinavir Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Amprenavir HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on September 21, 2017