Expanded Access Program for Maraviroc At Multiple Centers

ViiV Healthcare

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426660

2006-004306-50 (EudraCT Number)

A4001050

EAP (Other Identifier)

Details and patient eligibility

About

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Enrollment: 1,047 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
• Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
• Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Exclusion criteria

• Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Trial design

1,047 participants in 1 patient group

1

Experimental group

Treatment:

Drug: maraviroc