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

Phase 1

• Conditions: HIV-1 infection; MedDRA version: 17.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004435-31-BE
• Lead Sponsor: ViiV Healthcare UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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