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

NCT00116298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2011-04-25

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • AIDS

Interventions

DRUG

stavudine, efavirenz, lamivudine

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • France
  • Israel
  • Italy
  • Mexico
  • Portugal
  • Puerto Rico
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00116298 on ClinicalTrials.gov