DATA
A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL.
Sponsor study identifier
interventional
120
1 country
30
Study Start
February 23, 2011
Actual (reported)Primary Completion
March 29, 2011
Actual (reported)Study Completion
January 7, 2013
Actual (reported)A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 7, 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2011
Actual (reported)March 29, 2011
Actual (reported)January 7, 2013
Actual (reported)June 19, 2013
Actual (reported)August 26, 2013
Actual (reported)Viral load of HIV-1 < 50 cp/ml
To evaluate the virological efficacy and safety at week 48 of 2 regimens atazanavir/ritonavir (ATZ/r) 300/100 mg or darunavir/ritonavir (DRV/r) 800/100 mg, each in combination with a fixed-dose of tenofovir/emtracitabine in HIV-1 treatment-naïve subjects with CD4 counts below 200 µL
48 weeks
• Proportion of subjets with virologic efficacy
24 weeks
• Proportion of subjects with confirmed virologic failure
24 weeks
Viral lod of HIV-1 on seminal fluid
W00,W4 et W48
Immunologic response
W-4,W2,W4,W12,W24 and W48
Differenciation and activation of lymphocytes
W0,W2,W4,W12,W24 and W48
The patient included in this Group 1 will receive their first antiretroviral regimen included : ATV + TDF/FTC (or Abacavir/Lamivudine, \[ABC/3TC\], if contre indicated of TDF/FTC) The dose : atazanavir/ritonavir 300/100mg/day and TDF/FTC 245 /200 mg day, 3 pills once a day, during 48 weeks during a meal
The patients included in this Group 2 will receive their first antiretroviral regimen included Group 2 : DRV+ TDF/FTC (or ABC/3TC if contre-indicated of TDF/FTC) The dose : darunavir/ritonavir 800/100mg/day and TDF/FTC 245 /200 mg day, 4 pills once a day, during 48 weeks during a meal
The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules
The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules
Hopital Zobda Quitman
Fort de France, Martinique, 97261, France
Centre Hospitalier D'Argenteuil
Argenteuil, 95107, France
Hopital Saint-Jacques
Besançon, 25000, France
Hopital Avicenne
Bobigny, 93000, France
Hopital Jean Verdier
Bondy, 93143, France
Hopital Saint-Andre
Bordeaux, 33075, France
Chu Cote de Nacre
Caen, 14033, France
Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabie A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.
Laurence LS SLAMA, PhD
Hospital TENON
Roland RL LANDMAN, PhD
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
120 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2013
First Posted
August 26, 2013
Study Start
February 23, 2011
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hopital Louis Mourier
Colombes, 92700, France
Hopital Le Bocage
Dijon, 21034, France
Hopital Raymond Poincare
Garches, 92380, France
C.H.D de Vendee
La Roche-sur-Yon, 85925, France
Hopital Dupuytren
Limoges, 87000, France
Hopital Sainte-Marguerite
Marseille, 13274, France
Centre Hospitalier de Melun
Melun, 77011, France
Hopital L'Archet
Nice, 06202, France
Hopital Lariboisiere
Paris, 75010, France
Hopital Saint Antoine
Paris, 75012, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Hopital Necker
Paris, 75015, France
Hopital Bichat
Paris, 75018, France
Hopital Tenon
Paris, 75020, France
Hopital Pitie-Salpetriere
Paris, 75651, France
Hopital Cochin
Paris, 75674, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Hopital Saint-Jean Roussillon
Perpignan, 66046, France
Hopital Rene Dubos
Pontoise, 95303, France
C.H.R.A
Pringy, 74374, France
Hopital Civil
Strasbourg, 67000, France
Hopital Gustave Dron
Tourcoing, 59208, France
Hopital Bretonneau
Tours, 37044, France
Primary Completion
March 29, 2011
Actual (reported)Study Completion
January 7, 2013
Actual (reported)Last Updated
January 12, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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