CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Results: A trend was found for arm*time interaction (p=.056), with 6-month effect size d=1.2 and 12-month effect size d=.45, in favour of improved NR performance in MA arm compared to control arm over time (Figure 1). BG glutamate concentration (a marker of excitotoxicity) was stable in MA arm but tended to increase in control arm at 12 months (interaction: p<.08; β =.-35).

Conclusions: This pilot study provides feasibility, tolerability, proof-of-concept and preliminary evidence for clinically significant neurocognitive improvement and potential stabilization of glutamate excitotoxicity in CART enhancement with MA in virally suppressed HAND patients. 442 Similar Neurocognitive Performance in Patients on ATV/r Monotherapy vs Triple Therapy Giada Caramatti 1 ; Francesca Ferretti 1 ; Antonio Di Biagio 2 ; Amedeo Capetti 3 ; Andrea Antinori 4 ; Fiorella Di Sora 5 ; Roberta Gagliardini 6 ; ConcettaVinci 1 ; Adriano Lazzarin 1 ; Laura Galli 1 1 San Raffaele Scientific Institute, Milan, Italy; 2 Azienda Ospedaliera San Martino, Genoa, Italy; 3 L. Sacco University Hospital, Milan, Italy; 4 National Institute for Infectious Diseases IRCCS Lazzaro Spallanzani, Rome, Italy; 5 Ospedale San Giovanni, Rome, Italy; 6 Catholic University of the Sacred Heart, Rome, Italy Background: To assess efficacy in Central Nervous System (CNS), we evaluated neurocognitive performance in patients (pts) on atazanavir/ritonavir (ATV/r) monotherapy compared to ATV/r triple therapy. Methods: MODAt (NCT01511809) is a multicentric, randomized, open-label, non-inferiority trial. Pts on ATV/r 300/100mg+2 N(t)RTIs since ≥ 48 weeks, virologically suppressed since ≥ 24 weeks, were randomized to ATV/r (arm A) or to maintain ATV/r+2N(t)RTIs (Arm B). This analysis included patients treated with either ATV/r triple therapy or monotherapy (with no re-intensification due to virological failure) who underwent neuropsychological (NP) evaluation at baseline, week 48 and, if not discontinued, at week 96. The NP tests assessed multiple cognitive domains including attention/concentration (Digit Symbol [DS]), learning/memory (Rey Auditory Verbal Learning Test [RAVLT], Rey Recall [RAVLT rec]); psychomotor speed (Trail Making Test–Part A [TMTA], Grooved Pegboard [GP]), executive functioning (TMT–Part B [TMTB]), language (Semantic [SF] and Phonemic fluency [PF]), and gross motor (finger tapping [FT]). Age, sex and education adjusted scores were used. Depression was assessed using the CES-D scale. Results are expressed as median (interquartile range). ANOVA for repeated measures and McNemar test were applied for longitudinal analysis. Results: Sixty-five pts were examined (Arm A=28, Arm B=37): 88%males; age, 40 (35-46) years; education, 13 (12-15) years; duration of HIV-infection, 5 (2-7) years; CD4+ nadir, 293 (224-388) cells/ μ L; baseline CD4+, 610 (431-774) cells/ μ L, pre-ART HIV-RNA 4.67 (4-5.26) log10cp/mL; HCV co-infection (15%); none with AIDS diagnosis. Baseline NP findings were similar between the two arms with the exception of TMT-B scores that were worse in arm B compared to arm A (p=0.018). At baseline, CES-D score was abnormal (score>23) in 11 (17%) pts, borderline (score: 17-23) in 10 (15%) pts, with no significant changes of these proportions during follow-up. NP scores improved significantly over 96 weeks in five of nine tests [Figure] with no trend differences between arms. The proportion of pts with HIV-Associated Neurocognitive Disorders (HAND) dropped from 66% at baseline to 37% at week 96 with no differences between arms.

Poster Abstracts

Conclusions: In subjects successfully treated for 96 weeks, we observed an improvement in the majority of explored NP test performances with similar trends in patients treated with ATV/r-monotherapy or ATV/r triple therapy.

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CROI 2015