Maraviroc Compassionate Use

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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This study was cancelled prior to enrollment.

Conditions

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Human Immunodeficiency Virus Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Maraviroc

Intervention Type DRUG

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.

Interventions

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Maraviroc

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No