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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Open, multicenter, non randomized, single arm, pilot trial.
Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Experimental | Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events) | Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric symptoms | Presence and Intensity of neuropsychiatric symptoms (visual scale 0 to 10) | 24 weeks |
| Interruptions of the medication for any reason | Interruptions of the medication due to adverse effects, virological failure, or any other reason |
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Inclusion Criteria:
Exclusion criteria:
Additional Exclusion Criteria (for patients recruited at the Costa del Sol Hospital in Marbella only):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria Luque | Contact | +34 951 29 19 77 | gloria.luque@fimabis.org | |
| Alejandro Pérez | Contact | +34 951 29 14 47 | alejandro.perez@fimabis.org |
| Name | Affiliation | Role |
|---|---|---|
| Julian Olalla, PhD | SAS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa del Sol University Hospital | Marbella | Málaga | 29603 | Spain |
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| 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 |
|---|---|
| D000068898 | Raltegravir Potassium |
| D020125 | Mutation, Missense |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Multicenter, open, non-randomized pilot trial.
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| 24 weeks |
| Change in quality of life (WHOQoL-bref questionnaire) | World Health Organization Quality of Life: 1-100 in 4 domains. 100 best score | 24 weeks |
| Variation of the result in the Hospital, Anxiety and Depression (HAD) scale | Hospital, anxiety and depression: 0 y 7 indicates no case, between 8 & 10 indicates doubtful case and scores of 11 and above are possibly anxiety and depression cases. | 24 weeks |
| Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale | Pittsburgh Sleep Quality Index: Score 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas. | 24 weeks |
| Variation of the result in the Epworth scale | Diurnal drowsiness: If score is less than 6 points, daytime sleepiness is low or absent; between 7 and 8, is in the average of the population and if it is higher than 9 its drowsiness is excessive. | 24 weeks |
| Variation of the result in the COLUMBIA-SUICIDE SEVERITY RATING (CSSR) scale | COLUMBIA-SUICIDE SEVERITY RATING SCALE: progressive score depending of each question answer | 24 weeks |
| Magnetic Resonance Imagigng (MRI) analysis for 10 of the patients recruited at the Costa del Sol Hospital (pilot subestudy) |
| 24 weeks |
| Clínic University Hospital | Barcelona | 08036 | Spain |
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| San Carlos Clinical Hospital | Madrid | 28040 | Spain |
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| 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 |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |