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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116298
Recruitment Status : Completed
First Posted : June 29, 2005
Last Update Posted : April 25, 2011
Information provided by:
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
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 : January 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. Efficacy: Changes in CD4 cell counts

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116298

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United States, California
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Berkeley, California, United States
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West Hollywood, California, United States
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Tygerberg, Western Cape, South Africa
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Barcelona, Spain
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Madrid, Spain
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Bangkok, Thailand
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Nontaburi, Thailand
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information: Identifier: NCT00116298     History of Changes
Other Study ID Numbers: AI455-110
First Posted: June 29, 2005    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers