Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily... | NCT02626923

Studies
Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients

NCT02626923

Sponsor

Nicholaos C Bellos, MD

Status

Completed

Last Update Posted

Dec 10, 2015Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Drug-induced Hypotension

Interventions

Not provided

Countries

Not provided

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Dec 9, 2015

First Posted Date

Dec 10, 2015Estimated

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

Dec 9, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

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

Hypotension does not occur with Maraviroc at a dose of 600 mg/day

Detailed Description

A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients on once daily Maraviroc		Maraviroc tablet 600 mg once daily 48 weeks

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypotension related to once daily Maraviroc dosing	Blood pressure lowering secondary to Maraviroc 600 mg once daily dosing	48 Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epzicom Maraviroc once daily dosing

Exclusion Criteria:

Maraviroc with any other back bone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

HIV impacted individual on therapy with once daily Maraviroc

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicholaos C Bellos, MD	Southwest Infectious Disease, PA	Study Chair

Locations

Not provided