Raltegravir as Early Therapy in African-Americans Living With HIV Study (REAL)
This is a single arm, longitudinal study to examine the safety, tolerability, and pharmacokinetic and metabolic characteristics of Raltegravir among 40 African-American, HIV-infected, patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection|
- Assess Raltegravir tolerability, acceptability, and adherence among African-American men and women initiating HIV therapy. 2. Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks
Drug: Raltegravir + Truvada
Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks
Purpose: This study will be a single arm, prospective cohort study to examine the safety, efficacy, and pharmacokinetic and metabolic characteristics of Raltegravir in African-American men and women.
Participants: 40 HIV positive, ARV treatment-naive, African-American women and men (estimated to be 70% men, 30% women)
Procedures (methods): Subjects will receive Raltegravir 400 mg BID along with Truvada for 104 weeks.
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7215|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||David A Wohl, MD||University of North Carolina, Chapel Hill|