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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David A Wohl, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00667433
First received: April 22, 2008
Last updated: September 3, 2013
Last verified: September 2013

April 22, 2008
September 3, 2013
June 2008
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00667433 on ClinicalTrials.gov Archive Site
Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Raltegravir as Early Therapy in African-Americans Living With HIV Study
CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Raltegravir + Truvada
Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks
Other Names:
  • MK-0518; Isentress
  • emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Single Arm
Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks
Intervention: Drug: Raltegravir + Truvada
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667433
CID 0706
No
David A Wohl, MD, University of North Carolina, Chapel Hill
David A Wohl, MD
Merck Sharp & Dohme Corp.
Principal Investigator: David A Wohl, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP