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

Phase 3

Completed

• Conditions: HIV Infections; AIDS

• Registration Number: NCT00116298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-06-28
• Study First Submitted QC: 2005-06-28
• Study First Posted: 2005-06-29
• Disposition First Submitted: 2010-01-28
• Disposition First Submitted QC: 2010-01-28
• Disposition First Posted: 2010-02-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Efficacy: Changes in CD4 cell counts

Trial Locations

Locations (1)

Local Institution; 🇹🇭 Nontaburi, Thailand