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

Primary Purpose

HIV Infections, AIDS

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
stavudine, efavirenz, lamivudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antivirals, HIV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Outcomes

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

Full Information

First Posted
June 28, 2005
Last Updated
April 8, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00116298
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS
Keywords
Antivirals, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
stavudine, efavirenz, lamivudine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy: Changes in CD4 cell counts

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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