A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.|
|Study Start Date:||January 1995|
|Study Completion Date:||May 1999|
|Primary Completion Date:||May 1999 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002349
|United States, California|
|San Diego Naval Hosp|
|San Diego, California, United States, 921345000|
|United States, Virginia|
|Naval Med Ctr|
|Portsmouth, Virginia, United States, 237085100|
|United States, Washington|
|Northwest Med Ctr|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||. ., .|