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

Drug-induced Hypotension Clinical Trial

Official title:

Observational Study of the Safety and Efficacy of Nucleoside Reverse Transcriptase Inhibitor Backbones With Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in Antiretroviral Therapy-Naive Patients and First-Switch Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626923
• Other study ID #: 759-TBC
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: December 9, 2015
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2015
• Source: Southwest Infectious Disease Clinical Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Epzicom Maraviroc once daily dosing

Exclusion Criteria:

• Maraviroc with any other back bone

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Drug-induced Hypotension
• Hypotension

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nicholaos C Bellos, MD	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension related to once daily Maraviroc dosing	Blood pressure lowering secondary to Maraviroc 600 mg once daily dosing	48 Weeks	Yes