Clinical trial NCT01776996: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
Official title: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Infection, Human Immunodeficiency Virus
Keywords: Expanded access, HIV, maraviroc
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2013-01-28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.


Eligibility criteria: Inclusion Criteria:

* 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.
* Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
* 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.
* Subject agrees to the specified study procedures.

Exclusion Criteria:

* Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
* 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.
* Contra-indications to use of maraviroc as described in the Investigator Brochure.
* Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Modena
country: Italy
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: N.Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Soweto
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Dundee
country: South Africa
facility: GSK Investigational Site
city: Gauteng
country: South Africa
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
city: Pretoria North
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Westdene
country: South Africa
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Lugano
country: Switzerland
facility: GSK Investigational Site
city: Zuerich
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: