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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000515-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir/Ritonavir + 2 nucleos(t)idos | Active Comparator | Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg) |
|
| Darunavir/ritonavir + Lamivudine | Experimental | Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir/Ritonavir | Drug | Darunavir/ritonavir (800/100 mg): QD (quaque die ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable viral load | Undetectable viral load <50 copies/ml according to the FDA snapshot algorithm | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable viral load | Undetectable viral load < 50 copies/ml according to the FDA snapshot algorithm | Week 24 |
| Proportion of patients with viral load < 200 copies/ml |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of genotypic resistance mutations | Mutations in patients viral failure | Week 48 |
| Change in proportion of genotypic resistance mutations | week 48 |
Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding woman
Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:
History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:
- Viral load prior to abandonment was <50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .
Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.
The use of concomitant medication not permitted
Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
Any laboratory results of the following: hemoglobin<8,0 g/dl; neutrophils <750 cells/µl; platelets <50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)
Any clinical or analytic event that, in the investigator judgment, condition the patient safety
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| Name | Affiliation | Role |
|---|---|---|
| Jose R Arribas, MD | Hospital Universitario La Paz | Study Director |
| Federico Pulido, MD | Hospital Universitario 12 de Octubre | Study Director |
| Esteban Ribera, MD | Hospital Vall d'Hebron | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | |||
| Hospital General Universitario de Alicante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29020293 | Derived | Pulido F, Ribera E, Lagarde M, Perez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodriguez-Gomez FJ, Tellez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734. |
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|
| Lamivudine | Drug | Lamivudine (300mg) : QD |
|
|
| Emtricitabine/tenofovir or abacavir/lamivudine | Drug | Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD |
|
|
Proportion of patients with viral load < 200 copies/ml according to FDA snapshot algorithm
| week 48 |
| Proportion of patients who present viral load ≥ 50 copies /ml one time | Viral load ≥ 50 copies/ml | From basal visit until week 48 visit |
| Proportion of patients who present viral load ≥ 50 copies /ml more tan two times | Viral load ≥ 50 copies /ml | From basal visit until week 48 visit |
| Proportion of patients who maintained viral load < 50 copies/ml in all determinations | Viral load < 50 copies/ml | week 48 |
| Median of change cells CD4/µl count from basal to week 48 | CD4/µl | week 48 |
| Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48 | week 48 |
| Change in renal function | Change in glomerular filtration | week 48 |
| Change in proportion of patients with renal tubular dysfunction | week 48 |
| Alicante |
| Spain |
| Hospital Universitario Germans Trias i Pujol | Badalona | Spain |
| Hospital Clinic | Barcelona | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitario Vall D'Hebron | Barcelona | Spain |
| Hospital Universitario Reina Sofía | Córdoba | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
| Complejo Hospitalario de Huelva | Huelva | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | Spain |
| Hospital Universitario Fundación Alcorcón | Madrid | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | Spain |
| Hospital universitario Infanta Leonor | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Príncipe de Asturias | Madrid | Spain |
| Hospital de Mataró | Mataró | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital Universitario Donostia | San Sebastián | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D019259 | Lamivudine |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| C492871 | abacavir, lamivudine drug combination |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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