Status:
COMPLETED
Fuzeon Viral Decay Pilot Study
Lead Sponsor:
Canadian Immunodeficiency Research Collaborative
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV-1
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-...
Eligibility Criteria
Inclusion
- Patient must be HIV infected
- Patient must be \> 18 years old
- Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
- Patient must have a viral load \< 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
- Patient must have a CD4 count above 400 cells/mm3 in last 3 months
- Female patient must agree to use two methods of birth control or abstinence during the period of the study
- Patient has to have signed full informed consent
Exclusion
- Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
- Patient who have taken mono or dual antiretroviral therapy
- Patient who have had a viral load \> 50 copies/mL on any antiretroviral regimen
- Patient with any of the following abnormal laboratory test results in screening:
- Hemaglobin \< 100 g/L
- Neutrophil count \< 750 cells/uL
- Platelet count \< 50,000 cells/L
- AST or ALT \> 5X the upper limit of normal
- Creatinine \> 250 umol/L
- Patient with a malignancy
- Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
- Patient with an active AIDS-defining illnesses in the past six months
- Patients who are pregnant
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00334022
Start Date
February 1 2006
End Date
January 1 2010
Last Update
June 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6