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

Tracking Information
First Received Date ^ICMJE	June 28, 2005
Last Updated Date	April 8, 2011
Start Date ^ICMJE	January 2001
Primary Completion Date	January 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 11, 2005)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00116298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 11, 2005)	Efficacy: Changes in CD4 cell counts
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections AIDS
Intervention ^ICMJE	Drug: stavudine, efavirenz, lamivudine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	900
Completion Date	January 2005
Primary Completion Date	January 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Belgium, Brazil, Canada, France, Israel, Italy, Mexico, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Thailand

Administrative Information
NCT Number ^ICMJE	NCT00116298
Other Study ID Numbers ^ICMJE	AI455-110
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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