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

Tracking Information
First Received Date ^ICMJE	December 1, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
Official Title ^ICMJE	The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Ritonavir Drug: Amprenavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00006591
Responsible Party
Study ID Numbers ^ICMJE	313A, APV-430
Study Sponsor ^ICMJE	Gathe, Joseph, M.D.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP