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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004435-31-BE

Enrollment

162

Registered

2012-01-31

Start date

2012-05-15

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection MedDRA version: 17.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862

Interventions

Trade Name: CELSENTRI 300mg Film coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MARAVIROC CAS Number: 376348-65-1 Current Sponsor code: GSK382178 Other descriptive name: C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Primary

Measure	Time frame
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 Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

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 Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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Countries

Argentina, Belgium, Italy, Poland, Russian Federation, South Africa, Switzerland, Thailand

Contacts

Public ContactIan W. Taylor

ViiV Healthcare UK Limited

Ian.W.Taylor@viivhealthcare.com+44208380 6230

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026