Maraviroc Compassionate Use

Phase 3WithdrawnNCT00719823

ViiV Healthcare

Overview

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

This study was cancelled prior to enrollment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Human Immunodeficiency Virus Type 1

Interventions

MaravirocDRUG

Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen. * Have only CCR5-tropic HIV-1 virus * CD4+ cell count \< 200 cells/mm3 Exclusion Criteria: * CXCR4- or dual/mixed-tropic HIV-1 virus * Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness * Patients who are pregnant or breast feeding an infant or planning to become pregnant.

Outcomes

Primary Outcomes

Safety analysis will include all subjects who receive at least one dose of study drug

Time frame: Two Years

Secondary Outcomes

Safety analysis will include all subjects who receive at least one dose of study drug

Time frame: Two years

Data from ClinicalTrials.gov

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