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

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ClinicalTrials.gov Identifier: NCT02302950
Recruitment Status : Active, not recruiting
First Posted : November 27, 2014
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment
HIV Infection Drug: raltegravir

Study Type : Observational
Actual Enrollment : 254 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]
  2. Assess tolerability of raltegravir by capturing symptoms [ Time Frame: 24 weeks of therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302950


Locations
United States, Texas
Thomas Street Clinic
Houston, Texas, United States, 77009
Sponsors and Collaborators
The University of Texas Health Science Center, Houston

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
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 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
Anti-HIV Agents
HIV Integrase Inhibitors
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action