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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT | Registry Identifier | 2009-014742-28 |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Pfizer | INDUSTRY |
| Janssen-Cilag Ltd. |
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The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.
Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.
After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).
We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir |
|
| arm 2 | Active Comparator | darunavir, ritonavir, emtricitabine/tenofovir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine | Drug | raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30 | 30 months | |
| Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine CHERET, PH | Tourcoing Hospital | Principal Investigator |
| Caroline LASCOUX-COMBE, PH | Saint Louis Hospital, Paris | Principal Investigator |
| Laurence MEYER, Professor | Methodologist, INSERM U1018 | Study Chair |
| Bruno HOEN, Professor | Saint Jacques Hospital, CHU Besançon | Principal Investigator |
| Isabelle RAVAUX, PH | Conception Hospital, Marseille | Principal Investigator |
| Christine ROUZIOUX, Professor | Virology Investigator, Necker Hospital Paris | Principal Investigator |
| Alain VENET, PH | Immunology Investigator, INSERM U1012 Bicêtre | Principal Investigator |
| Daniel OLIVE, Professor | Immunology Investigator, Cancerology Institut Marseille | Principal Investigator |
| Gianfranco PANCINO, PH | Immunology Investigator, Pasteur Institut Paris |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gustave Dron | Tourcoing | 59208 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28708873 | Derived | Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017. | |
| 25701561 |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000077592 | Maraviroc |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| INDUSTRY |
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|
| darunavir; ritonavir; emtricitabine/tenofovir | Drug | darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD. |
|
| Changes in cell-associated HIV-DNA between baseline and M24 | 24 Months |
| Evolution of the CD4 and CD8 between D0 and M24 | 24 months |
| Tolerability of trial treatments | 24 months |
| Number and type of ARV mutations in virological failures and change in CCR5 tropism | 24 Months |
| Brigitte AUTRAN, Professor | Immunology Investiigator, INSERM U543 Paris | Principal Investigator |
| Derived |
| Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18. |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D013844 | Thiazoles |
| 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 |