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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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

  Show 63 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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

ClinicalTrials.gov processed this record on May 21, 2013