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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| CIHR Canadian HIV Trials Network | NETWORK |
The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.
Interventions:
Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.
Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic management strategy | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To prospectively determine differences in other virologic parameters through follow up between patients being switched to a salvage regimen with or without a STI. | ||
| 2. To prospectively determine differences in change in CD4 count through follow up and at 24, 48 and 60 weeks following randomization between patients being switched to a salvage regimen with or without a STI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Loutfy, MD | University Health Network, Toronto, On | Study Chair |
| Joel Singer, MD | Canadian Trials Network, Vancouver, B.C. | Study Director |
| Janet Raboud, Dr. | Univeristy Health Network, Toronto, On | Study Director |
| Stephen Shafran, MD | University of Alberta, Edmonton, Alberta | Study Director |
| Bill Cameron, MD | Ottawa Hospital, Ottawa, On | Study Director |
| Sylvie Trottier, MD | Clinique Medicale L'Actuel, Montreal, Quebec | Study Director |
| Richard Harrigan, MD | B.C. Centre of Excellence, Vancouver, B.C. | Study Director |
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| 3. To prospectively determine differences in the development or reactivation of opportunistic infections and survival between patients being switched to a salvage regimen with or without a STI at 60 weeks following randomization |
| 4. To determine the proportion of virus of patients being treated with a STI that converts to wild-type and how that relates to the virologic response (% of patients with undetectable viral load sustained for 3 months). |
| 5. To determine the impact of the STI on quality of life measures. |
| 6. To determine the genotypic resistance pattern of virus from patients who fail treatment after suppression to <50 copies/mL on the salvage regimen and to compare results in those who do and do not receive an STI. |