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-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (\> 5 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
1ml BID
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.
Time frame: 6 months
To determine the change of proviral HIV-1 DNA from baseline to month 3
To determine the change of proviral HIV-1 DNA from baseline to month 3
Time frame: 3 months
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm
Time frame: 9 months
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
Time frame: 9 months
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
Time frame: 9 months
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
Time frame: 9 months
To determine the half-life of HIV in resting CD4+ T cells
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To determine the half-life of HIV in resting CD4+ T cells
Time frame: 9months
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell
Time frame: 9 months
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)
Time frame: 9 months