Status:
COMPLETED
Raltegravir as Early Therapy in African-Americans Living With HIV Study
Lead Sponsor:
David A Wohl, MD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00667433
Start Date
June 1 2008
End Date
December 1 2011
Last Update
March 3 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215
2
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157