Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00116298

Collaborator

(none)

900

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections AIDS	Drug: stavudine, efavirenz, lamivudine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period []

Secondary Outcome Measures

Efficacy: Changes in CD4 cell counts []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Completed d4T studies AI455-096 or AI455-099
Have demonstrated compliance with the study medication and treatment visits
Provide written informed consent
Agree to use a barrier method of birth control (such as condoms) during the study
Have a negative pregnancy test within 72 hours prior to start of study medication

Exclusion Criteria:

Are pregnant or breast-feeding
Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
Have certain other conditions or prior treatments that might interfere with study continuation
Need to take certain medications that should not be taken with EFV

Contacts and Locations

Locations

	Site	City	State	Country
1	Local Institution	Berkeley	California	United States
2	Local Institution	Los Angeles	California	United States
3	Local Institution	West Hollywood	California	United States
4	Local Institution	Washington	District of Columbia	United States
5	Local Institution	Ft. Lauderdale	Florida	United States
6	Local Institution	Orlando	Florida	United States
7	Local Institution	Tampa	Florida	United States
8	Local Institution	Indianapolis	Indiana	United States
9	Local Institution	Wichita	Kansas	United States
10	Local Institution	Louisville	Kentucky	United States
11	Local Institution	Brookline	Massachusetts	United States
12	Local Institution	Las Vegas	Nevada	United States
13	Local Institution	Reno	Nevada	United States
14	Local Institution	New York	New York	United States
15	Local Institution	Winston-Salem	North Carolina	United States
16	Local Institution	Oklahoma City	Oklahoma	United States
17	Local Institution	Dallas	Texas	United States
18	Local Institution	Houston	Texas	United States
19	Local Institution	Hampton	Virginia	United States
20	Local Institution	San Isidro	Buenos Aires	Argentina
21	Local Institution	Rosario	Santa Fe	Argentina
22	Local Institution	Buenos Aires		Argentina
23	Local Institution	Cordoba		Argentina
24	Local Institution	Gent		Belgium
25	Local Institution	Liege		Belgium
26	Local Institution	Salvador	Bahia	Brazil
27	Local Institution	Belo Horizonte - MG	Minas Gerais	Brazil
28	Local Institution	Botucatu	Sao Paulo	Brazil
29	Local Institution	Santos	Sao Paulo	Brazil
30	Local Institution	Vancouver	British Columbia	Canada
31	Local Institution	Toronto	Ontario	Canada
32	Local Institution	Montreal	Quebec	Canada
33	Local Institution	Bordeaux Cedex		France
34	Local Institution	Lyon Cedex 03		France
35	Local Institution	Nantes Cedex 01		France
36	Local Institution	Paris Cedex 13		France
37	Local Institution	Rennes Cedex 9		France
38	Local Institution	Rehovot		Israel
39	Local Institution	Tel Hashorner		Israel
40	Local Institution	Bari		Italy
41	Local Institution	Bergamo		Italy
42	Local Institution	Firenze		Italy
43	Local Institution	Milano		Italy
44	Local Institution	Napoli		Italy
45	Local Institution	Pisa		Italy
46	Local Institution	Torino		Italy
47	Local Institution	Mexico	Distrito Federal	Mexico
48	Local Institution	Coimbra		Portugal
49	Local Institution	Lisboa		Portugal
50	Local Institution	Cotto Laurel		Puerto Rico
51	Local Institution	San Juan		Puerto Rico
52	Local Institution	Moscow		Russian Federation
53	Local Institution	St. Petersburg		Russian Federation
54	Local Institution	Singapore		Singapore
55	Local Institution	Bedford Gardens	Gauteng	South Africa
56	Local Institution	Hatfield	Gauteng	South Africa
57	Local Institution	JOhannesburg	Gauteng	South Africa
58	Local Institution	Westdene	Gauteng	South Africa
59	Local Institution	Tygerberg	Western Cape	South Africa
60	Local Institution	Barcelona		Spain
61	Local Institution	Madrid		Spain
62	Local Institution	Bangkok		Thailand
63	Local Institution	Nontaburi		Thailand