A Retrospective Analysis of Raltegravir Use in Minority H... | NCT02302950

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

NCT02302950

Sponsor

The University of Texas Health Science Center, Houston

Status

Unknown status

Last Update Posted

May 22, 2017Actual

Enrollment

254Actual

Phase

Not provided

Conditions

HIV Infection

Interventions

raltegravir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Nov 26, 2014

First Posted Date

Nov 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2017

Last Update Posted Date

May 22, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tanvir K. Bell, MD, Associate Professor of Medicine, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

254Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
women that picked up raltegravir 2013		minority women that picked up raltegravir at Thomas street Health Center 2013	Drug: raltegravir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
raltegravir	Drug	HIV therapy component	women that picked up raltegravir 2013

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load		24 weeks of therapy

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Street Clinic		Houston	Texas	77009	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068898	Raltegravir Potassium

Ancestor Terms

ID	Term
D011760	Pyrrolidinones
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided