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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00667433
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir + Truvada Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : June 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Names:
  • MK-0518; Isentress
  • emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Raltegravir Potassium
Emtricitabine
Tenofovir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors