Status:
COMPLETED
Expanded Access Program for Maraviroc At Multiple Centers
Lead Sponsor:
ViiV Healthcare
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
Eligibility Criteria
Inclusion
- Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
- Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
- Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.
Exclusion
- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1047 Patients enrolled
Trial Details
Trial ID
NCT00426660
Start Date
February 1 2007
End Date
June 1 2010
Last Update
June 29 2016
Active Locations (361)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Alabama
Birmingham, Alabama, United States, 35294-2050
2
Health Services Center
Hobson City, Alabama, United States, 36201
3
El Rio, Special Immunology Associates
Tucson, Arizona, United States, 85745
4
Health for Life Clinic PLLC
Little Rock, Arkansas, United States, 72207