Maraviroc Compassionate Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719823
Recruitment Status : Withdrawn
First Posted : July 22, 2008
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):
ViiV Healthcare

July 18, 2008
July 22, 2008
May 4, 2016
August 2008
May 2010   (Final data collection date for primary outcome measure)
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ]
Same as current
Complete list of historical versions of study NCT00719823 on Archive Site
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ]
Same as current
Not Provided
Not Provided
Maraviroc Compassionate Use
Maraviroc Compassionate Use
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.
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Human Immunodeficiency Virus Type 1
Drug: 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: Drug: Maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
ViiV Healthcare
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP