An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc.

• Conditions: HIV-1 infection; MedDRA version: 14.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004435-31-IT
• Lead Sponsor: VIIV HEALTHCARE UK LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment. 3. Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria. 4. Subject agrees to the specified study procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial. 2. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. Contra-indications to use of maraviroc as described in the Investigator Brochure. 4. Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA;Main Objective: The primary objective is to provide continued access to maraviroc for those subjects who have completed previous clinical studies of maraviroc and continue to receive clinical benefit from treatment with the drug, but cannot access maraviroc either commercially or because it is not otherwise available.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA