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NCT02302950 Clinical Trial

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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02302950
Other study ID # HSC-MS-14-0559
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 21, 2014
Last updated May 19, 2017
Start date September 2014
Est. completion date December 2017

Study information
Verified date May 2017
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 254
Est. completion date December 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• raltegravir
HIV therapy component

Locations
Country Name City State
United States Thomas Street Clinic Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load 24 weeks of therapy
Secondary Capture data on concomitant conditions that may have led to participants switching to raltegravir from medical records (eg. Diabetes mellitus) 24 weeks of therapy
Secondary Assess tolerability of raltegravir by capturing symptoms 24 weeks of therapy
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