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

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

June 23, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00667433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Raltegravir + Truvada

Study Arms / Comparison Groups

Other: Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00667433

Responsible Party

David A. Wohl, MD, The University of North Carolina at Chapel Hill

Study ID Numbers ^ICMJE

CID 0706

Study Sponsor ^ICMJE

The University of North Carolina, Chapel Hill

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

David A Wohl, MD

The University of North Carolina at Chapel Hill

Information Provided By

The University of North Carolina, Chapel Hill

Verification Date

June 2009

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