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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000985-31 | EudraCT Number |
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The reason for the premature termination was the failure to reach the required number of participants.
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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir + Lamivudine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir (1200 mg once a day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure | therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience | Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic i Provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
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| Lamivudine |
| Drug |
Lamivudine (300 mg once a day) |
|
Changes on Pittsburgh Sleep Quality Index for neurological toxicity |
| 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity | Changes on plasma lipids cholesterol LDL | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity | Changes on plasma lipids cholesterol HDL | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity | Changes on plasma lipids triglycerides | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity | Changes on dual energy x-ray absorptiometry bone density | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity | Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort | 48 weeks |
| Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions | Proportion of drug-drug interaction with antirretroviral treatment | 48 weeks |
| Therapeutic failure | 24 weeks |
| Virological failure | Defined as two consecutive measurements of plasma viral load above 50 copies/ml | 24 weeks |
| Virological failure | Defined as two consecutive measurements of plasma viral load above 50 copies/ml | 48 weeks |
| Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) | 48 weeks |
| Changes from baseline in cholesterol total | 24 weeks |
| Changes from baseline in HDL | 24 weeks |
| Changes from baseline in triglycerides | 24 weeks |
| Changes from baseline in insulin resistance (HOMA-IR) | 24 weeks |
| Changes from baseline in cholesterol LDL | 24 weeks |
| Changes from baseline in cholesterol LDL | 48 weeks |
| Changes from baseline in cholesterol total | 48 weeks |
| Changes from baseline in cholesterol HDL | 48 weeks |
| Changes from baseline in triglycerides | 48 weeks |
| Changes from baseline in and insulin resistance (HOMA-IR) | 48 weeks |
| Changes from baseline in body fat composition | 48 weeks |
| Changes from baseline in immune activation markers including CD38 | 48 weeks |
| Changes from baseline in immune activation markers including HLA-DR | 48 weeks |
| Changes from baseline in biomarkers of inflammation IL-6, | 48 weeks |
| Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein | 48 weeks |
| Changes from baseline in biomarkers of mononuclear activation SD-14 | 48 weeks |
| Changes from baseline in biomarkers of mononuclear activation SD-163 | 48 weeks |
| Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) | 24 weeks |
| Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) | 48 weeks |
| Change from baseline in EQ-5D-5L | 24 weeks |
| Change from baseline in EQ-5D-5L | 48 weeks |
| Incidence of adverse events | 48 weeks |
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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