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| Name | Class |
|---|---|
| Merck Frosst Canada Ltd. | INDUSTRY |
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This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.
The study will be performed only on two sites
The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| switch from etravirine to doravirine | Experimental | switches to doravirine, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | switches from etravirine to doravirine, in experienced HIV patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who maintain virologic control . | Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL. | 24 weeks |
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Inclusion Criteria:
- Adult (18 Y.O. or more) women and men infected with HIV.
Exclusion Criteria:
High level of resistance to doravirine according to historical resistance tests.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioannis vertzagias | Contact | 5142853401 | ivertzagias@cmql.ca | |
| benoit trottier, MD | Contact | 5142853401 | bentrotte@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Du Quartier Latin | Not yet recruiting | Montreal | Quebec | H2L 4E9 | Canada |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2023 | |
| Reset | Jan 4, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2023 | Jan 4, 2024 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000592662 | doravirine |
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A pilot, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance
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| Clinique Du Quartier Latin | Recruiting | Montreal | Quebec | H2L 4E9 | Canada |
|
| CHU Martinique | Not yet recruiting | Fort-de-France | Fort de France | CS 90632 | Martinique |
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |