Raltegravir as Early Therapy in African-Americans Living With HIV Study - Full Text View

Sponsor:	The University of North Carolina, Chapel Hill
Collaborator:	Merck
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00667433

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Raltegravir Truvada

U.S. FDA Resources

Further study details as provided by The 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the pharmacokinetics of Raltegravir in African-American men and women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Contacts

Contact: David Ragan, RN	919-966-2623	davidrag@med.unc.edu
Contact: Donna Pittard, RN	919-843-6512	donna_pittard@med.unc.edu

Locations

United States, North Carolina
The University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599-7215
Contact: David Ragan, RN 919-966-2623 davidrag@med.unc.edu
Contact: Donna Pittard, RN 919-843-6512 donna_pittard@med.unc.edu
Principal Investigator: David A Wohl, MD
Sub-Investigator: Joseph Eron, MD
Sub-Investigator: Michelle Floris-Moore, MD
Sub-Investigator: Angela Kashuba, PhD
Sub-Investigator: Heidi Swygard, MD
Sub-Investigator: Kristine Patterson, MD
Sub-Investigator: Cynthia Gay, MD
Sub-Investigator: Charles van der Horst, MD
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Sandra M Hauser 336-716-4267 smhauser@wfubmc.edu
Contact: Abbie Beltz, PhD 336-716-9134 abeltz@wfubmc.edu
Principal Investigator: Aimee Wilkin, MD, MPH
Sub-Investigator: Paul S Pegram, Jr, MD
Sub-Investigator: Vera Luther, MD
Sub-Investigator: Marina Nunez, MD, PhD
Sub-Investigator: Luis Barroso, MD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Merck

Investigators

Principal Investigator:

David A Wohl, MD

The University of North Carolina at Chapel Hill

More Information

Publications:

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.

Responsible Party:	The University of North Carolina at Chapel Hill ( David A. Wohl, MD )
Study ID Numbers:	CID 0706
Study First Received:	April 22, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00667433 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

HIV
African American
treatment naïve

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 05, 2009