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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

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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

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

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