Maraviroc Compassionate Use

ViiV Healthcare

Status and phase: Withdrawn; Phase 3

Conditions: Human Immunodeficiency Virus Type 1

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719823

A4001068

Details and patient eligibility

About

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.

Full description

This study was cancelled prior to enrollment.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Other group

Treatment:

Drug: Maraviroc