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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001683-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of this study is to compare the impact of two combination of two tablets once daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients with primary HIV-1 infection.
Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment, national multicenter trial evaluating two treatments in patients with primary HIV-1 infection.
Comparison of the two combinations regarding:
Viral reservoir at W48
Early inhibition of viral replication,
Plasmatic and cellular cumulative viremia at W48,
Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio,
Activation parameters decrease,
Adherence to treatments,
Treatments tolerance,
Adverse events,
Quality of life (by self-administered questionnaires). Study of the pharmacokinetics / dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral loads.
50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS CO 06 PRIMO cohort will be offered
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir + Emtricitabine/Tenofovir | Experimental | Patients will take Dolutegravir 50 mg (= Tivicay, 1 tablet per day) with Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks |
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| Darunavir/Cobicistat + Emtricitabine/Ténofovir | Active Comparator | Patients will take Darunavir 800 mg / Cobicistat 150 mg (=Rezolsta, 1 tablet per day) + Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | Oral use, 50mg/day |
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| Measure | Description | Time Frame |
|---|---|---|
| HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48 | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative cellular viremia up to week 48 | week 48 | |
| Cumulative plasmatic viremia (HIV-1 RNA) at week 48 | week 48 | |
| Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values < 50 copies / mL. |
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Inclusion Criteria:
Age ≥ 18 years at screening visit.
Patients with primary HIV-1 infection: Any results achieved in the previous 10 days of inclusion visit will be taken into account. If the Enzyme Linked ImmunoSorbent Assay (ELISA) test result does not dissociate the signals antibodies and p24 antigen or in case of rapid test result :
If the ELISA test result dissociated p24 antigen and antibodies signals:
ELISA Ac - / p24 - and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.
ELISA Ac - / p24 + confirmed by a positive HIV-1 RNA.
ELISA Ac + / p24 + or - and WB-HIV1 [0-5] band (s) or IB-HIV-1 [0-3] band(s) confirmed by a positive HIV-1 RNA.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Chéret, MD, PhD | Hôpital Bicêtre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Bicetre | All the Regions of the Country (40 Centers) | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35762503 | Result | Cheret A, Bauer R, Meiffredy V, Lopez P, Ajana F, Lacombe K, Morlat P, Lascoux C, Reynes J, Calin R, Abel S, Goujard C, Rouzioux C, Avettand-Fenoel V, Meyer L. Once-daily dolutegravir versus darunavir plus cobicistat in adults at the time of primary HIV-1 infection: the OPTIPRIM2-ANRS 169 randomized, open-label, Phase 3 trial. J Antimicrob Chemother. 2022 Aug 25;77(9):2506-2515. doi: 10.1093/jac/dkac207. |
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| Darunavir-cobicistat | Drug | Oral use, 800-150mg/day |
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| Emtricitabine-Tenofovir | Drug | Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg |
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| week 48 |
| Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48 | week 2, week 4, week 8, week 12, week 24, week 36, week 48 |
| Percentage of patients with HIV-1 RNA <50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48 | week 2, week 4, week 8, week 12, week 24, week 36, week 48 |
| Proportion of patients with HIV-1-RNA plasma below the ultrasensitive technique quantification threshold at week 2, week 4, week 8, week 12, week 24, week 36 and week 48 | week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Total DNA-HIV levels measured in PBMC at week 2, week 4, week 8, week 12, week 24, week 36 and week 48 | week 2, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Total DNA-HIV levels measured in PBMC: changes between week 0 and week 48. | between week 0 and week 48 |
| CD4 and CD8 counts and percentage at week 2, week 4, week 8, week 12, week 24, week 36, week 48. | week 2, week 4, week 8, week 12, week 24, week 36, week 48 |
| CD4 and CD8 counts and percentage changes between week 0 and week 48. | between week 0 and week 48. |
| CD4/CD8 ratio at week 2, week 4, week 8, week 12, week 24, week 36, week 48. | week 2, week 4, week 8, week 12, week 24, week 36, week 48 |
| CD4/CD8 ratio changes between week 0 and week 48. | between week 0 and week 48. |
| Pharmacokinetic: mean concentrations between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease. | between week 0 and week 48 |
| Pharmacokinetic: cumulative AUC between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease. | between week 0 and week 48 |
| Trial treatments tolerance using self-administered questionnaires of symptoms experienced. | week 0, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Reported quality of life using self-administered questionnaire (PROQOL-HIV questionnaire). | between week 0 and week 48 |
| Number, nature and time of occurrence of stage 3 or 4 clinical and biological adverse events (using ANRS scale to grade severity of adverse events in adults). | between week 0 and week 48 |
| HIV infection progression defined by occurrence of B or C stage clinical events or death between week 0 and week 48 | between week 0 and week 48 |
| Evolution of Metabolic disorders assessed by measurement of cholesterol, triglycerides, blood glucose and lipase | between week 0 and week 48 |
| Evolution of Renal function assessed by urea and serum creatinine. | between week 0 and week 48 |
| Adherence to treatments using self-administered questionnaires | week 4, week 8, week 12, week 24, week 36 and week 48 |
| Adherence to treatments using pills' counts by local pharmacist | week 4, week 8, week 12, week 24 and week 36 |
| Adherence to treatments using MEMS (Medical Event Monitoring System) data collected during the first 3 months | between week 0 and week 12 |
| ID | Term |
|---|---|
| C562325 | dolutegravir |
| C000711687 | cobicistat mixture with darunavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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