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

May 19, 2017 updated by: Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HIV infected minority women at Thomas Street Health Center that picked up raltegravir in 2013

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
women that picked up raltegravir 2013
minority women that picked up raltegravir at Thomas street Health Center 2013
HIV therapy component
Other Names:
  • issentress

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks of therapy
Assess tolerability of raltegravir by capturing symptoms
Time Frame: 24 weeks of therapy
24 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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