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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2006-006268-42 | |||
| FIS grant: EC07/90642 |
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There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | tenofovir plus emtricitabine plus efavirenz |
|
| 2 | Experimental | tenofovir plus emtricitabine plus lopinavir-ritonavir |
|
| 3 | Experimental | tenofovir plus emtricitabine plus atazanavir-ritonavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir + emtricitabine + efavirenz | Drug | tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Miró, MD | Hospital Clinic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Catalonia | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25831464 | Derived | Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567. |
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| tenofovir + emtricitabine + lopinavir-ritonavir | Drug | tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose |
|
| tenofovir + emtricitabine + atazanavir-ritonavir | Drug | tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD |
|
| 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 |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| C098320 | efavirenz |
| D061466 | Lopinavir |
| C000718687 | atazanavir, ritonavir drug combination |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011744 | Pyrimidinones |
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