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Maraviroc Compassionate Use

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ClinicalTrials.gov Identifier: NCT00719823
Recruitment Status : Withdrawn
First Posted : July 22, 2008
Last Update Posted : May 4, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Type 1 Drug: Maraviroc Phase 3

Detailed Description:
This study was cancelled prior to enrollment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maraviroc Compassionate Use
Study Start Date : August 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ]

Secondary Outcome Measures :
  1. Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719823


Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00719823     History of Changes
Other Study ID Numbers: A4001068
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by ViiV Healthcare:
Maraviroc Compassionate Use

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Slow Virus Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents