1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP
October 25 - 29, 2003 Warsaw, Poland
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9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland |
| 7.3 Phase III/IV Trials F7/4 - DIDANOSINE (DDI) IN TREATMENT-EXPERIENCED HIV-INFECTED PATIENTS:RESULTS FROM A RANDOMIZED DOUBLE-BLIND STUDY (AI454-176 JAGUAR) |
| (1) St-Louis Hosp., Paris, France,2 Pitié Hosp., Paris, France,3 Archet Hosp., Nice, France,4 G.de Chauliac Hosp., Montpellier, France,5 Lagny Hosp., France,6 Bellevue Hosp., St Etienne, France,7 BMS Rueil, France |
Background: Antiviral efficacy of ddI and previous exposure to ddI in antiretroviral-experienced patients (pts) are not well known.
Objective: To investigate the efficacy of ddI in combination with other antiretroviral (ARV) in pts with incomplete viral suppression.
Methods: Randomized, double-blinded study. Pts under stable ARV therapy and with plasma HIV RNA >1000 cps/ml were randomized (2:1) to add ddI or placebo (P) to their regimen for 4 weeks. Primary efficacy : mean change in plasma HIV RNA from baseline to week 4.
Results: 168 pts received either ddI (n= 110) or P (n=58). At baseline, median HIV RNA level (log10) : 3.8, median CD4 count: 378 cells/mm3, median nb of TAMs and NAMs : 3 and 4. At W4, median HIV RNA decrease from baseline in ddI and P arm were respectively (log10): - 0.6 and +0.07 (p<0.0001). At W4, 33 pts in ddI arm and 3 in P arm had HIV RNA < 400 cps/ml (p=0.0001). 68.4 % of pts received a prior therapy with ddI (> 3 months prior to screening). In these pts, median HIV RNA decrease was -0.48 in ddI arm and + 0.07 in P arm (interaction prior ddi-treatment p = 0.18). Median HIV RNA decrease in ddI arm was -0.57 in pts having received prior ddI therapy, without L74V (n = 92). Nine pts in ddI arm and three in P arm complained of diarrhea (p=0.55).
Conclusion: In treatment-experienced pts, ddI retains significant antiviral activity, even in pts with previous exposure to ddI.
<<p>Presenting Author: Professor Molina Jean-Michel, Service des Maladies Infectieuses-Hôpital St Louis, 1 avenue Claude Vellefaux, 75010, Paris, France, Phone: 33.1.42.49.90.65031025
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