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

ViiV Healthcare

Status

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Continued Access Arm

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01776996

116278

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.