Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment - Tabular View

Tracking Information
First Received Date ^ICMJE	February 10, 2000
Last Updated Date	October 1, 2007
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 NCT00004584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
Official Title ^ICMJE	Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
Brief Summary	The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.
Detailed Description	This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atazanavir Drug: Ritonavir Drug: Saquinavir
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	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml. Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness). Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load. Will most likely respond well to the study drugs, as shown by the results of a lab test. Are at least 18 years old. Agree to use effective barrier methods of birth control (such as condoms). Are available for follow-up for at least 48 weeks. Exclusion Criteria Patients will not be eligible for this study if they: Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment. Have only recently become HIV positive. Abuse alcohol or drugs. Have severe diarrhea within 30 days of study entry. Have hemophilia. Have a history of pancreatitis. Have hepatitis within 30 days of study entry. Have peripheral neuropathy (a painful condition affecting the nervous system). Are unable to take medications by mouth. Are pregnant or breast-feeding.
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, Canada, France, Germany, Italy

Administrative Information
NCT ID ^ICMJE	NCT00004584
Responsible Party
Study ID Numbers ^ICMJE	302B, AI424-009
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP