A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Overview

Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in 2007. It is currently one of the preferred treatment regimens for HIV by the Department of Health and Human Services. It has become a widely used antiretroviral therapy option for HIV infected patients. It provides good tolerability and a favorable lipid profile for patients when compared to some other antiretroviral treatment options. Little data is reported about efficacy in a minority patient population. Moreover, data in an indigent minority population in the United States has not been aggregated before. Therefore this study will investigate the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2015

Interventions

  • Drug: raltegravir
    • HIV therapy component

Arms, Groups and Cohorts

  • women that picked up raltegravir 2013
    • minority women that picked up raltegravir at Thomas street Health Center 2013

Clinical Trial Outcome Measures

Primary Measures

  • Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load
    • Time Frame: 24 weeks of therapy

Secondary Measures

  • Capture data on concomitant conditions that may have led to participants switching to raltegravir from medical records (eg. Diabetes mellitus)
    • Time Frame: 24 weeks of therapy
  • Assess tolerability of raltegravir by capturing symptoms
    • Time Frame: 24 weeks of therapy

Participating in This Clinical Trial

Inclusion Criteria

1. HIV-infected women who picked up raltegravir in the year 2013 at Thomas Street Health Center. 2. Minority women -Black/African American, Hispanic/Latino Exclusion Criteria:

  • n/a

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tanvir K. Bell, MD, Associate Professor of Medicine – The University of Texas Health Science Center, Houston

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