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

NCT02302950 | Unknown

• 1 other identifier: HSC-MS-14-0559
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Keywords

HIV infection; raltegravir use; women

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load

  24 weeks of therapy

Secondary Outcomes (2)

• Capture data on concomitant conditions that may have led to participants switching to raltegravir from medical records (eg. Diabetes mellitus)

  24 weeks of therapy

• Assess tolerability of raltegravir by capturing symptoms

  24 weeks of therapy

Study Arms (1)

women that picked up raltegravir 2013

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

Drug: raltegravir

Interventions

raltegravir DRUG

HIV therapy component

Also known as: issentress

women that picked up raltegravir 2013

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Thomas Street Clinic

Houston, Texas, 77009, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 27, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

US (1)