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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00116298
First received: June 28, 2005
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
HIV Infections
AIDS
Drug: stavudine, efavirenz, lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment: 900
Study Start Date: January 2001
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116298

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00116298     History of Changes
Other Study ID Numbers: AI455-110
Study First Received: June 28, 2005
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Antivirals
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Lamivudine
Stavudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014