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

June 28, 2005
April 8, 2011
January 2001
January 2005   (final data collection date for primary outcome 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
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Complete list of historical versions of study NCT00116298 on ClinicalTrials.gov Archive Site
Efficacy: Changes in CD4 cell counts
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Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
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

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.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Drug: stavudine, efavirenz, lamivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   France,   Israel,   Italy,   Mexico,   Portugal,   Puerto Rico,   Russian Federation,   Singapore,   South Africa,   Spain,   Thailand
 
NCT00116298
AI455-110
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Bristol-Myers Squibb
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Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP