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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir (RAL) 1200mg QD vs Darunavir/Cobicistat (DRV-cb) 800-150mg QD both in combination with alafenamide/emtricitabine (TAF/FTC) in patients with Human Inmunodefficiency Virus (HIV) infection and CD4<200 cells/microL
The trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised HIV infected patients (with an initial CD4 count <200 cells/μl) naive to antiretroviral therapy.
Included subjects will be randomized two to one (2:1) to RAL 1200mg QD plus FTC/TAF or DRV/cb (800-150mg) plus FTC/TAF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAL 1200 QD | Experimental | Start treatment with Raltegravir (RAL) 1200mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) |
|
| DRV/cb | Active Comparator | Start treatment with Darunavir/Cobicistat (DRV/cb) 800-150mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: RAL QD | Drug | Prescription of 2x RAL 600mg (1200MG) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC | Number of patients that will improve when having raltegravir vs darunavir | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virological failure | Number of patients in virological failure at week 48. | 48 weeks |
| Compare the proportion of patients who interrupt the treatment for any reason | Number of patients that interrupt the treatment for any reason after 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| D013607 | Tablets |
| D000069454 | Darunavir |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Active comparator: DRV/cb | Drug | Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily |
|
|
| 48 weeks |
| Analyze change (percentage) in the number of CD4 lymphocytes | Percentage of change in the number of CD4 lymphocytes after 48 weeks. | 48 weeks |
| Compare the proportion of patients with CD4>200 cells/μL at end of intervention | Compare the proportion of patients with CD4>200 cells/μL at end of intervention. | 48 weeks |
| Percentage change in total cholesterol (TC) | Percentage of patients with change in total cholesterol (TC), | 48 weeks |
| Percentage change in LDL and HDL cholesterol | Percentage of patients with change in LDL and HDL cholesterol | 48 weeks |
| Percentage change in triglycerides | Percentage of patients with change the percentage change in triglycerides after 48 weeks | 48 weeks |
| Percentage change in TC/HDL ratio | Percentage of patients with change in TC/HDL ratio | 48 weeks |
| Change in Cardiovascular Risk 10-year predictive value (REGICOR). | Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR). | 48 weeks |
| Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation | Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation. | 48 weeks |
| 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 |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D013844 | Thiazoles |
| D001393 | Azoles |