Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels.
Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥ 4.5).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir / Ritonavir | Experimental |
| |
| Atazanavir / Ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir / Ritonavir + Tenofovir / Emtricitabine | Drug | oral, 800/100 mg, qd + oral, 300/200 mg, qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total cholesterol | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol | 24, 48 and 96 weeks | |
| Cardiovascular risk according to the Framingham scale. | 24, 48 and 96 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29745457 | Derived | Gonzalez-Cordon A, Domenech M, Camafort M, Martinez-Rebollar M, Torres B, Laguno M, Rojas J, Lonca M, Blanco JL, Mallolas J, Gatell JM, de Lazzari E, Martinez E. Subclinical cardiovascular disease in patients starting contemporary protease inhibitors. HIV Med. 2018 May 10. doi: 10.1111/hiv.12619. Online ahead of print. | |
| 25389256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atazanavir / Ritonavir + Tenofovir / Emtricitabine | Drug | oral, 300/100 mg, qd + oral, 300/200 mg, qd |
|
| Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index)) | 24, 48 and 96 weeks |
| inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin) | 24, 48 and 96 weeks |
| RNA viral load <50 copies / mL | 24, 48 and 96 weeks. |
| CD4+ cells count | 24, 48 and 96 weeks |
| clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms. | 24, 48 and 96 weeks |
| distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan | 48 and 96 weeks |
| Martinez E, Gonzalez-Cordon A, Ferrer E, Domingo P, Negredo E, Gutierrez F, Portilla J, Curran A, Podzamczer D, Ribera E, Murillas J, Bernardino JI, Santos I, Carton JA, Peraire J, Pich J, Deulofeu R, Perez I, Gatell JM; ATADAR Study Group. Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: a randomized clinical trial. Clin Infect Dis. 2015 Mar 1;60(5):811-20. doi: 10.1093/cid/ciu898. Epub 2014 Nov 10. |
| 24417772 | Derived | Martinez E, Gonzalez-Cordon A, Ferrer E, Domingo P, Negredo E, Gutierrez F, Portilla J, Curran A, Podzamczer D, Murillas J, Bernardino JI, Santos I, Carton JA, Peraire J, Pich J, Perez I, Gatell JM; ATADAR Study Group. Early lipid changes with atazanavir/ritonavir or darunavir/ritonavir. HIV Med. 2014 Jul;15(6):330-8. doi: 10.1111/hiv.12121. Epub 2014 Jan 12. |
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069446 | Atazanavir Sulfate |
| 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 |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided