Raltegravir as Early Therapy in African-Americans Living With HIV Study

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Raltegravir + Truvada

• Registration Number: NCT00667433
• Lead Sponsor: David A Wohl, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Study Start: 2008-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• HIV-1 infection documented by HIV serology or detectable viral load
• Self-described as African-American
• Less than 7 days cumulative of prior HIV therapy
• Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to study entry
• Able to provide informed consent
• In the opinion of the investigator, able to comply with study medication and procedures
• ALT (SGPT) < or equal to 3.0 x ULN within 45 days prior to study entry
• GRF > 59 as calculated by MDRD within 45 days prior to study entry
• All women of reproductive potential (who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum or urine β-HCG pregnancy test performed within 48 hours before entry.

All study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use at least one reliable method of contraception (e.g., condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal-based contraception), simultaneously while receiving the protocol-specified medication(s) and for 6 weeks after stopping the medication(s). If oral birth control pills, hormone patches, or hormone injections are used for contraception, then a second method of contraception must be used.

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Prior receipt of Raltegravir
• Any condition which in the opinion of the investigator is likely to interfere with follow-up or ability to take the study medication appropriately

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Raltegravir + Truvada	Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
Determine the pharmacokinetics of Raltegravir in African-American men and women.	2 years

Trial Locations

Locations (2)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States