- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302950
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
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:
- HIV-infected women who picked up raltegravir in the year 2013 at Thomas Street Health Center.
- 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:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Raltegravir Potassium
Other Study ID Numbers
- HSC-MS-14-0559
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.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV-1 Infection | HIV Antibodies | Neutralizing Antibody | Viral Load | Monoclonal AntibodyUnited States
Clinical Trials on raltegravir
-
Massachusetts General HospitalMerck Sharp & Dohme LLCCompletedHIV | Neurotoxicity | HIV-associated Neurocognitive DisorderUnited States
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico, South Africa, Argentina, Brazil, Botswana
-
ViiV HealthcareCompletedInfection, Human Immunodeficiency VirusUnited States
-
Merck Sharp & Dohme LLCCompleted
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedInfection, Human Immunodeficiency Virus IGermany, Spain, France, Australia, United States, Canada, United Kingdom, Italy, Russian Federation
-
ANRS, Emerging Infectious DiseasesCompletedHIV-1 Infection | PREGNANCYFrance
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedHIV Infections | Infection, Human Immunodeficiency VirusUnited States, France, Netherlands, Spain, Taiwan, Australia, Belgium, Russian Federation, Canada, United Kingdom, Mexico, Italy, South Africa, Romania, Argentina, Hungary, Poland, Chile, Greece, Brazil
-
IrsiCaixaCompleted