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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00004584

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Atazanavir Drug: Ritonavir Drug: Saquinavir	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Jan 1, 2002

Actual Study Completion Date :

Jan 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sorra Research Ctr / Med Forum	Birmingham	Alabama	United States	35203
2	AIDS Healthcare Foundation	Los Angeles	California	United States	90027
3	Robert Scott MD	Oakland	California	United States	94609
4	Univ of California - Davis Med Ctr / CARES	Sacramento	California	United States	95817
5	Avalar Medical Group	Tarzana	California	United States	91356
6	Yale Univ School of Medicine / AIDS Program	New Haven	Connecticut	United States	06510
7	Community Research Initiative of South Florida	Coral Gables	Florida	United States	33146
8	HIV Clinical Research	Fort Lauderdale	Florida	United States	33316
9	Infectious Disease Research Institute	Tampa	Florida	United States	33614
10	Infectious Disease Specialists of Atlanta	Decatur	Georgia	United States	30033
11	Louisiana State Univ Med Ctr / HIV Outpatient Clinic	New Orleans	Louisiana	United States	70112
12	Albany Med College	Albany	New York	United States	12208
13	St Vincents Hosp / Clinical Research Program	New York	New York	United States	10011
14	Univ Hosps of Cleveland	Cleveland	Ohio	United States	44106
15	The Research and Education Group	Portland	Oregon	United States	97210
16	Julio Arroyo	West Columbia	South Carolina	United States	29169
17	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37212
18	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
19	Texas Tech Health Sciences Ctr	El Paso	Texas	United States	79905
20	Houston Clinical Research Network / Div of Montrose Clinic	Houston	Texas	United States	77006
21	Ottawa General Hospital	Ottawa	Ontario	Canada
22	Toronto Hosp	Toronto	Ontario	Canada
23	Montreal Chest Institute	Montreal	Quebec	Canada
24	Hopital Pellegrin Tripode	Bordeaux		France
25	Hopital De L'Hotel Dieu	Nantes		France
26	Hopital De L'Archet 1	Nice		France
27	Srev Du Pr Gentilini	Paris Cedex 13		France
28	Hopital De Haut Leveque	Pessac		France
29	Hospital Gustave Dron	Tourcoing		France
30	Hopital Paul Brousse	Villejuif		France
31	Brennerstr 71	Hamburg		Germany
32	Georg-Str 46	Hanover		Germany
33	Praxisgemeinschaft	Munich		Germany
34	Reparto Malattie Infettive	Antella		Italy
35	Clinical Malattie Infettive	Milano		Italy
36	Ospedale Luigi Cacco Moroni	Milano		Italy
37	Clinical Malattie Infettive / Univ Modena	Modena		Italy
38	Ospedale degli Infermi	Rimini		Italy