Clinical trial NCT00116298: Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
AIDS
Keywords: Antivirals
HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-06-29
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Efficacy: Changes in CD4 cell counts
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: West Hollywood
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Wichita
country: United States
facility: Local Institution
state: Kansas
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Brookline
country: United States
facility: Local Institution
state: Massachusetts
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Reno
country: United States
facility: Local Institution
state: Nevada
city: New York
country: United States
facility: Local Institution
state: New York
city: Winston-Salem
country: United States
facility: Local Institution
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Hampton
country: United States
facility: Local Institution
state: Virginia
city: San Isidro
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Belo Horizonte - MG
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Santos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Nantes Cedex 01
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Rehovot
country: Israel
facility: Local Institution
city: Tel Hashorner
country: Israel
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Coimbra
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Cotto Laurel
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Bedford Gardens
country: South Africa
facility: Local Institution
state: Gauteng
city: Hatfield
country: South Africa
facility: Local Institution
state: Gauteng
city: JOhannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Westdene
country: South Africa
facility: Local Institution
state: Gauteng
city: Tygerberg
country: South Africa
facility: Local Institution
state: Western Cape
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Nontaburi
country: Thailand
facility: Local Institution
Study officials:
References: