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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116298
• Other study ID #: AI455-110
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2005
• Last updated: April 8, 2011
• Start date: January 2001
• Est. completion date: January 2005

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• stavudine, efavirenz, lamivudine

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	San Isidro	Buenos Aires
Belgium	Local Institution	Gent
Belgium	Local Institution	Liege
Brazil	Local Institution	Belo Horizonte - MG	Minas Gerais
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Santos	Sao Paulo
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
France	Local Institution	Bordeaux Cedex
France	Local Institution	Lyon Cedex 03
France	Local Institution	Nantes Cedex 01
France	Local Institution	Paris Cedex 13
France	Local Institution	Rennes Cedex 9
Israel	Local Institution	Rehovot
Israel	Local Institution	Tel Hashorner
Italy	Local Institution	Bari
Italy	Local Institution	Bergamo
Italy	Local Institution	Firenze
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Pisa
Italy	Local Institution	Torino
Mexico	Local Institution	Mexico	Distrito Federal
Portugal	Local Institution	Coimbra
Portugal	Local Institution	Lisboa
Puerto Rico	Local Institution	Cotto Laurel
Puerto Rico	Local Institution	San Juan
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St. Petersburg
Singapore	Local Institution	Singapore
South Africa	Local Institution	Bedford Gardens	Gauteng
South Africa	Local Institution	Hatfield	Gauteng
South Africa	Local Institution	JOhannesburg	Gauteng
South Africa	Local Institution	Tygerberg	Western Cape
South Africa	Local Institution	Westdene	Gauteng
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Nontaburi
United States	Local Institution	Berkeley	California
United States	Local Institution	Brookline	Massachusetts
United States	Local Institution	Dallas	Texas
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Hampton	Virginia
United States	Local Institution	Houston	Texas
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Las Vegas	Nevada
United States	Local Institution	Los Angeles	California
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	New York	New York
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Orlando	Florida
United States	Local Institution	Reno	Nevada
United States	Local Institution	Tampa	Florida
United States	Local Institution	Washington	District of Columbia
United States	Local Institution	West Hollywood	California
United States	Local Institution	Wichita	Kansas
United States	Local Institution	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  France,  Israel,  Italy,  Mexico,  Portugal,  Puerto Rico,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy: Changes in CD4 cell counts

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm