Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
The University of Texas Health Science Center, Houston


Information provided by (Responsible Party)
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier
NCT02302950

First received: November 21, 2014
Last updated: May 19, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection

Drug : raltegravir

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Further study details as provided by Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston:

Primary Outcome Measures

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

Enrollment: 254
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
women that picked up raltegravir 2013
minority women that picked up raltegravir at Thomas street Health Center 2013
Drug: raltegravir

HIV therapy component

Other Name: issentress
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

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

Criteria

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02302950

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
More Information

More Information


Responsible Party: Tanvir K. Bell, MD, Associate Professor of Medicine, The University of Texas Health Science Center, Houston  
ClinicalTrials.gov Identifier: NCT02302950   History of Changes  
Other Study ID Numbers: HSC-MS-14-0559  
Study First Received: November 21, 2014  
Last Updated: May 19, 2017  

Keywords provided by Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston:

HIV infection
raltegravir use
women

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.