Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00005918
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

Detailed Description

Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-06-15
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-13
• Disposition First Submitted QC: 2011-04-13
• Disposition First Posted: 2011-04-25
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (77)

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States

Whitman Walker Clinic; 🇺🇸 Washington, District of Columbia, United States

IDC Research Initiative; 🇺🇸 Altamonte Springs, Florida, United States

Med Alternatives; 🇺🇸 Fort Lauderdale, Florida, United States

Hillsborough County Health Dept; 🇺🇸 Tampa, Florida, United States

The CORE Ctr; 🇺🇸 Chicago, Illinois, United States

Univ of Kansas School of Medicine; 🇺🇸 Wichita, Kansas, United States

Univ of Louisville; 🇺🇸 Louisville, Kentucky, United States

CRI of New England; 🇺🇸 Brookline, Massachusetts, United States

CRI - Springfield; 🇺🇸 Springfield, Massachusetts, United States

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