A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002349
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.

Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Detailed Description

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Study Timeline

• Study Start: 1995-01
• Primary Completion: 1999-05
• Study Completion: 1999-05
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

Naval Med Ctr; 🇺🇸 Portsmouth, Virginia, United States

Northwest Med Ctr; 🇺🇸 Seattle, Washington, United States

San Diego Naval Hosp; 🇺🇸 San Diego, California, United States