Back to resultsRaltegravir as Early Therapy in African-Americans Living With HIV Study (REAL)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Raltegravir + Truvada
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, African American, treatment naïve
Eligibility Criteria
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
Sites / Locations
- The University of North Carolina at Chapel Hill
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Determine the pharmacokinetics of Raltegravir in African-American men and women.
Full Information
NCT ID
NCT00667433
First Posted
April 22, 2008
Last Updated
March 1, 2017
Sponsor
David A Wohl, MD
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00667433
Brief Title
Raltegravir as Early Therapy in African-Americans Living With HIV Study
Acronym
REAL
Official Title
CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David A Wohl, MD
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, African American, treatment naïve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks
Intervention Type
Drug
Intervention Name(s)
Raltegravir + Truvada
Other Intervention Name(s)
MK-0518; Isentress, emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Intervention Description
Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Determine the pharmacokinetics of Raltegravir in African-American men and women.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wohl, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7215
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17721395
Citation
Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.
Results Reference
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Raltegravir as Early Therapy in African-Americans Living With HIV Study
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