Landman R. auteur aut IRD Koulla-Shiro S. auteur aut IRD Sow P. S. auteur aut IRD Ngolle M. auteur aut IRD Diallo M. B. auteur aut IRD Gueye N. F. N. auteur aut IRD Le Moing V. auteur aut IRD Eymard-Duvernay Sabrina auteur aut IRD Benalycherif A. auteur aut IRD Charpentier C. auteur aut IRD Peytavin G. auteur aut IRD Delaporte Eric auteur aut IRD Girard P. M. auteur aut IRD text journalArticle eng text/pdf born digital access Background: The aim of the present study was to determine appropriate tenofovir-based regimens meriting evaluation in large-scale randomized trials among sub-Saharan African patients. Methods: This was a randomized open-label 96-week prospective pilot study evaluating four first-line regimens: tenofovir/emtricitabine/nevirapine (group 1),tenofovir/lopinavir/ritonavir(group 2), tenofovir/emtricitabine/zidovudine (group 3) and tenofovir/emtricitabine/ efavirenz (group 4) in antiretroviral-naive, HIV-1-infected patients in Senegal and Cameroon. The primary end point was defined as an HIV-1 RNA viral load < 50 copies/ml (study detection limit) at week 16 in >= 50% of patients using intention-to-treat analysis. Results: At baseline, 119 patients included were 34% male, had a median plasma viral load of 5.4 log 10 copies/ml and median CD4(+) T-cell count of 200 cells/mm(3) range 53-358). The primary end point was achieved for groups 1, 3 and 4 (58% [n=31], 62% [n=29] and 53% [n=30], respectively), but not for group 2 (38% [n=29]). At week 96, undetectable HIV-1 RNA had been achieved in 74% of patients in group 1, 38% in group 2, 72% in group 3 and 73% in group 4. Patients with detectable HIV-1 RNA at week 16 were more likely to have baseline HIV-1 RNA >= 100,000 copies/ml (adjusted OR 5.56, 95% CI 1.72, 16.67). HIV mutations associated with protease inhibitor resistance emerged in three patients, all of whom were in group 2. Anaemia occurred in two group 3 patients and was the only serious treatment-related adverse event. Conclusions: Three efficient and safe tenofovir-based triple regimens were identified; the two-drug regimen (tenofovir/lopinavir/ritonavir) did not achieve the protocol-defined virological threshold of efficacy. specialized CAMEROUN SENEGAL 052 050 020 19 1 51-59 2014 1359-6535 https://www.documentation.ird.fr/hor/fdi:010062019 10.3851/imp2675 1359-6535 [F B010062019] https://www.documentation.ird.fr/hor/fdi:010062019 https://www.documentation.ird.fr/intranet/publi/2014/06/010062019.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2014-07-03 2017-08-23 fdi:010062019 fre