Maraviroc Compassionate Use
Primary Purpose
Human Immunodeficiency Virus Type 1
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Type 1 focused on measuring Maraviroc Compassionate Use
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Safety analysis will include all subjects who receive at least one dose of study drug
Secondary Outcome Measures
Safety analysis will include all subjects who receive at least one dose of study drug
Full Information
NCT ID
NCT00719823
First Posted
July 18, 2008
Last Updated
May 3, 2016
Sponsor
ViiV Healthcare
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00719823
Brief Title
Maraviroc Compassionate Use
Official Title
Maraviroc Compassionate Use
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Type 1
Keywords
Maraviroc Compassionate Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety analysis will include all subjects who receive at least one dose of study drug
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Safety analysis will include all subjects who receive at least one dose of study drug
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001068&StudyName=Maraviroc%20Compassionate%20Use
Description
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Learn more about this trial
Maraviroc Compassionate Use
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