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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
David A Wohl, MD

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: March 1, 2017
Last Verified: March 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Raltegravir + Truvada
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by David A Wohl, MD, University of North Carolina, Chapel Hill:

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. [ Time Frame: 2 years ]
Secondary Outcome Measures:
  • Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ]

Enrollment: 38
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Single Arm
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

Other Name:
  • MK-0518; Isentress
  • emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667433

Locations

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

Sponsors and Collaborators

David A Wohl, MD
Merck Sharp & Dohme Corp.

Investigators

Principal Investigator: David A Wohl, MD University of North Carolina, Chapel Hill
More Information

More Information


Responsible Party: David A Wohl, MD, Associate Professor, University of North Carolina, Chapel Hill  
ClinicalTrials.gov Identifier: NCT00667433   History of Changes  
Other Study ID Numbers: CID 0706  
Study First Received: April 22, 2008  
Last Updated: March 1, 2017  

Keywords provided by David A Wohl, MD, University of North Carolina, Chapel Hill:

HIV
African American
treatment naïve

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Raltegravir Potassium
Emtricitabine
Tenofovir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.