Maraviroc Compassionate Use

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00719823
First received: July 18, 2008
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus Type 1
Drug: Maraviroc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maraviroc Compassionate Use

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

This study was cancelled prior to enrollment.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719823

Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00719823     History of Changes
Other Study ID Numbers: A4001068
Study First Received: July 18, 2008
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
Maraviroc Compassionate Use

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014