Maraviroc Compassionate Use

Phase 3

Withdrawn

• Conditions: Human Immunodeficiency Virus Type 1
• Interventions: Drug: Maraviroc

• Registration Number: NCT00719823
• Lead Sponsor: ViiV Healthcare

Brief Summary

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.

Detailed Description

This study was cancelled prior to enrollment.

Study Timeline

• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Study Start: 2008-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Maraviroc	-

Primary Outcome Measures

Name	Time	Method
Safety analysis will include all subjects who receive at least one dose of study drug	Two Years

Secondary Outcome Measures

Name	Time	Method
Safety analysis will include all subjects who receive at least one dose of study drug	Two years