Multicenter, Safety Study Of Maraviroc

ViiV Healthcare

Status and phase: Completed; Phase 3

Conditions: HIV Infection; Acquired Immunodeficiency Syndrome

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478231

A4001063

Details and patient eligibility

About

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
• Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
• Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Exclusion criteria

• Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
• Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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209 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Maraviroc