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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Did not receive enfuvirtide | Placebo Comparator | patients were randomized to either receive enfuviratide or not receive it |
|
| enfuvirtide | Active Comparator | enfuvirtide 1ml BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfuvirtide | Drug | 1ml BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Colin Kovacs, MD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maple Leaf Medical Clinic | Toronto | Ontario | M5B 1L6 | Canada |
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| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
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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 |
| 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) | 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 | 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 | 9 months |
| To determine the half-life of HIV in resting CD4+ T cells | To determine the half-life of HIV in resting CD4+ T cells | 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 | 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) | 9 months |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |