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Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment Clinical research trials and Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment. Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment:
Location and Contact Information:
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817
United States
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Ottawa General Hospital
Ottawa, Ontario,
Canada
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, 70112
United States
Hopital De L'Hotel Dieu
Nantes, ,
France
Clinical Malattie Infettive / Univ Modena
Modena, ,
Italy
Albany Med College
Albany, New York, 12208
United States
Hopital Paul Brousse
Villejuif, ,
France
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Hospital Gustave Dron
Tourcoing, ,
France
Hopital Pellegrin Tripode
Bordeaux, ,
France
HIV Clinical Research
Ft. Lauderdale, Florida, 33316
United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
United States
Hopital De Haut Leveque
Pessac, ,
France
Toronto Hosp
Toronto, Ontario,
Canada
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Srev Du Pr Gentilini
Paris Cedex 13, ,
France
Hopital De L'Archet 1
Nice, ,
France
Avalar Medical Group
Tarzana, California, 91356
United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
United States
Praxisgemeinschaft
Munich, ,
Germany
Georg-Str 46
Hanover, ,
Germany
Montreal Chest Institute
Montreal, Quebec,
Canada
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Ospedale degli Infermi
Rimini, ,
Italy
Ospedale Luigi Cacco Moroni
Milano, ,
Italy
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
United States
Brennerstr 71
Hamburg, ,
Germany
Robert Scott MD
Oakland, California, 94609
United States
Reparto Malattie Infettive
Antella, ,
Italy
Clinical Malattie Infettive
Milano, ,
Italy
St Vincents Hosp / Clinical Research Program
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: 302B; AI424-009
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004584
Other Hiv Infections Studies:
1. A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
2. A Study of Decreased Mental Function Associated with HIV
3. Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
4. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
5. A Study of Megestrol Acetate in HIV-Infected Children
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Antella Clinical Trials
Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
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