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Evaluation of three 2 nd L ine A ntiretroviral regimens in Africa ( D akar, Y aounde)

ANRS project. Evaluation of three 2 nd L ine A ntiretroviral regimens in Africa ( D akar, Y aounde) « 2 LADY ». Promotor : - ANRS (JF Delfraissy) P.I : - Sinata Koulla Shiro (Cameroun) - P. Salif Sow(Sénégal) - E. Delaporte (IRD&CHU,Montpellier,France) CO-PI :

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Evaluation of three 2 nd L ine A ntiretroviral regimens in Africa ( D akar, Y aounde)

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  1. ANRS project Evaluation of three 2nd Line Antiretroviral regimens in Africa (Dakar, Yaounde) « 2 LADY »

  2. Promotor: - ANRS (JF Delfraissy) • P.I : - Sinata Koulla Shiro (Cameroun) - P. Salif Sow(Sénégal) - E. Delaporte (IRD&CHU,Montpellier,France) • CO-PI: - A.Calmy (MSF/Cameroun &HCUG,Suisse) - P.M Girard IMEA, Paris • Methodological center : - V. Le Moing (UMR 145, Montpellier)

  3. Rationale (1) • 2 million people are on ART (28% of those in need !) • AZT or d4T + 3TC and 1 NNRTI predominate in first line • To simplify second line therapy options (programatic level, cost,…)

  4. Rationale (2) • « Prioritizing second line ART within public health approach » (WHO 2006, 2007) • Second line regimens have not been rigourosly evaluated in the context of limited resources • Other option can be considered

  5. Regimens when thymidine analogs are used in 1st line therapy WHO 2007 1 RTV was rated only as a pharmacolgical booster for other Pis. 2 The combinattion of TDF/ddI was rated with consideration of a dose reduction of ddi to 200-250mg OD according to body weight. Hight Important Urgent

  6. Objectives of the study Main objective In case of virological failure to a first line ART To compare the virological response at week 48 of three different second line regimens : • FTC/3TC - TDF - Lopinavir/R WHO • Abacavir - ddi - Lopinavir/R Priorities and « Innovative strategy » with new ARV FTC-TDF-Darunavir/R

  7. Secondary objectives : To compare: • Clinical progression • Virological response at week 24 • Immunological response • Tolerance • Adherence

  8. Design Methods : Randomised,unblinded, no inferiority comparative trial in HIV-1 infected patients with HIVRNA > 1000c/ml , on a first line ARV since at least 12 months with 2 NRTI and 1 NNRTI Number of patients : n = 150 x3

  9. Feasability : Cameroun : Yaounde : Central Hospital (n= 5000) General Hospital (n= 1000) Douala : (MS F-CH project) n= 4000 patients under HAART Senegal : Dakar CHU Fann n= 1500

  10. Calendar and Questions • The protocol has been approved by ANRS and is funded • TIBOTEC for darunavir (5years)AND TMC125 (salvage therapy) :contract to be finalized • Protocol ready to be submitted for ethical/administrative clearences • Begin expected end 2008

  11. EDCTP 2 LADY plus Tanzania,South Africa,Germany,Belgium

  12. Day 0 1st randomization W52 2nd randomization W48 1st analysis W100 2nd analysis Phase 1 Phase 2

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