Management and antiretroviral treatment of HIV infection
The research activities of the Unit of Management and antiretroviral therapy of HIV infection are mainly focused on the evaluation of the efficacy of new antiretroviral drugs, on the quantification of the viral reservoir and on the evaluation of the performance of function markers of different apparatuses in relation to the use of specific drugs or in special settings of patients such as multidrug-resistant patients.
The availability of an electronic CFR has allowed to increase the data stored in the clinical and observational database (CSLHIV Cohort), which includes all clinical and laboratory data of adult patients with HIV infection who attended for care the Department of Infectious Diseases of the San Raffaele Hospital since 1991. To date, 10006 patients are registered, 5223 in active follow-up, 4724 (90%) with HIV-RNA <50 copies/mL.
The Unit of Management and antiretroviral therapy of HIV infection maintains collaborations between its database (CSLHIV Cohort) and some national networks (ICONA, ARCA, GEPPO) and european networks (NEAT, EuroSIDA, RESPOND, European Network for HIV / AIDS Surveillance).
The Unit of Management and antiretroviral therapy of HIV infection participates in randomized clinical trials conducted at international level aimed at verifying the efficacy of new molecules or new combinations of antiretroviral drugs. The Unit of Management and antiretroviral therapy of HIV infection participates in the following clinical trials aimed at evaluating:
1) in naive patients:
- the efficacy of bictegravir vs dolutegravir / emtricitabine / tenofovir alafenamide;
- the efficacy of long-acting cabotegravir + rilpivirine long-acting vs dolutegravir / lamivudine / abacavir;
- the efficacy of a dual dolutegravir + lamivudine vs dolutegravir + tenofovir + emtricitabine.
2) in patients treated with antiretroviral therapy and with viremia suppressed:
- the efficacy of the new combination of dolutegravir + rilpivirine vs 2NRTIs + an integrase inhibitor /NNRTI/ a PI/r.
Regarding individuals at risk of acquiring HIV infection, the Unit of Management and antiretroviral therapy of HIV infection participates in a study that assesses whether the combination of tenofovir alafenamide and emtricitabine taken once a day is safe and effective. as pre-exposure prophylaxis or PrEP (ie to prevent HIV infection).
The Unit of Management and antiretroviral therapy of HIV infection also promotes and conducts spontaneous and independent clinical trials in patients with HIV infection. The clinical studies in which the Unit of Management and antiretroviral therapy of HIV infection is mainly engaged, are:
- a study aimed at assessing residual viremia exposure in patients with virologic suppression and in treatment with a dual regimen based on dolutegravir and a reverse transcriptase inhibitor compared to the switch to a triple regimen with elvitegravir, emtricitabine, tenofovir alafenamide;
- a study aimed at assessing the possibility of spontaneous control of HIV-1 viral replication, after suspension of antiretroviral therapy, in subjects with chronic HIV infection in antiretroviral treatment, who ask to stop therapy and with viremia below 50 copies/mL for >10 years, undetectable peripheral HIV-DNA, CD4> 500 cells/mm3 and no evidence of residual viremia (defined as a viral load of HIV-1 between 1 and 49 copies/mL) for ≥5 years .
- a collection of biological samples and demographic information, clinical, laboratory, ART and non-ART treatments related to patients with HIV infection and suffering from multi-resistance to the 4 classes of antiretroviral drugs;
- an open-label, randomized study, in collaboration with SWISS HIV Cohort, which aims to assess whether an intervention involving the use of a smartphone application, which supports patients in the path of smoking cessation in combination with the use of a carbon monoxide (CO) meter in the breath, it is associated with a greater proportion of subjects who interrupt the smoking habit, at 6 months, compared to a normal counseling strategy.
- a multicenter observational clinical study, which aims to evaluate the incidence of STIs and HIV infection in subjects at risk, defined as men who have sex with men (MSM) and transgender (TG), aged 18-55 years, who have had at least two unprotected intercourse or a sexually transmitted infection (STI) in the 24 weeks prior to screening.
Achhra AC, Mocroft A, Reiss P, Sabin C, Ryom L, de Wit S, Smith CJ, d'Arminio Monforte A, Phillips A, Weber R, Lundgren J, Law MG; the D:A:D Study Group. Short-term weight gain after antiretroviral therapy initiation and subsequent risk of cardiovascular disease and diabetes: the D:A:D study. HIV Med. 2016; 17(4): 255-268.
De Luca A, Flandre P, Dunn D, Zazzi M, Wensing A, Santoro MM, Günthard HF, Wittkop L, Kordossis T, Garcia F, Castagna A, Cozzi-Lepri A, Churchill D, DeWit S, Brockmeyer NH, Imaz A, Mussini C, Obel N, Perno CF, Roca B, Reiss, P, Schülter E, Torti C, van Sighem A, Zangerle R, Descamps D; on behalf of CHAIN and COHERE in EuroCoord. Improved darunavir genotypic mutation score predicting treatment response for patients infected with HIRaben-1 subtype B and non-subtype B receiving a salvage regimen. J. Antimicrob. Chemother. 2016; 71(5): 1352-1360.
Di Biagio A, Cozzi-Lepri A, Prinapori R, Angarano G, Gori A, Quirino T, De Luca A, Costantini A, Mussini C, Rizzardini G, Castagna A, Antinori A, D'Arminio Monforte A; for the ICONA Foundation Study Group. Discontinuation of initial antiretroviral therapy in clinical practice: Moving toward individualized therapy. J. Acquired Immune Defic. Syndr. 2016; 71(3): 263-271.
Galli L Spagnuolo V Bigoloni A D'Arminio Monforte A, Montella F, Antinori A, Di Biagio A, Rusconi S, Guaraldi G, Di Giambenedetto S, Borderi M, Gibellini D, Caramatti G, Lazzarin A, Castagna A; on behalf of the MODAt Study Group. Atazanavir/ritonavir monotherapy: 96 week efficacy, safety and bone mineral density from the MODAt randomized trial. J. Antimicrob. Chemother. 2016; 71(6): 1637-1642.
Mocroft A, Lundgren JD, Ross M, Fux CA, Reiss P, Moranne O, Morlat P, Monforte Ad, Kirk O, Ryom L; for the Data Collection on Adverse events of Anti-HIV Drugs (D:A:D). Study Cumulative and current exposure to potentially nephrotoxic antiretrovirals and development of chronic kidney disease in HIV-positive individuals with a normal baseline estimated glomerular filtration rate: a prospective international cohort study. Lancet HIV 2016; 3(1) : e23-e32.
Saracino A, Lorenzini P, Lo Caputo S, Girardi E, Castelli F, Bonfanti P, Rusconi S, Caramello P, Abrescia N Mussini C Monno L d'Arminio Monforte A; for the ICONA Foundation Study Group. Increased risk of virologic failure to the first antiretroviral regimen in HIV-infected migrants compared to natives: data from the ICONA cohort. Clin Microbiol Infect. 2016; 22(3): 288.e1–288.e8.
Shepherd L, Borges Á, Ledergerber B, Domingo P, Castagna A, Rockstroh J, Knysz B, Tomazic J, Karpov I, Kirk O, Lundgren J, Mocroft A; on behalf of EuroSIDA in EuroCOORD. Infection-related and -unrelated malignancies, HIV and aging population. HIV Med. 2016; 17(8): 590-600.
Squillace N, Lorenzini P, Lapadula G, Bandera A, Cozzi-Lepri A, Rusconi S, Puoti M, Castagna A, Antinori A, Gori A, d'Arminio Monforte A; on behalf of the Icona Foundation Study Group. Triglyceride/HDL ratio and its impact on the risk of diabetes mellitus development during ART. J Antimicrob Chemother. 2016; 71(9): 2663-2669.
The Pediatric AIDS-Defining Cancer Project Working Group for IeDEA Southern Africa, TApHOD, and COHERE in EuroCoord Kaposi Sarcoma. Risk in HIV-infected children and adolescents on combination antiretroviral therapy from Sub-Saharan Africa, Europe, and Asia. Clin Infect Dis. 2016; 63(9): 1245-1253.
Winston A, Stöhr W, Antinori A, Arenas-Pinto A, Llibre JM, Amieva H, Cabié A, Williams I, Di Perri G, Tellez MJ, Rockstroh J, Babiker A, Pozniak A, Raffi F, Richert L; for the NEAT 001/Agence Nationale de Recherche sur le SIDA (ANRS) 143 Study Group. Host and disease factors are associated with cognitive function in European HIV-infected adults prior to initiation of antiretroviral therapy. HIV Med. 2016; 17(6): 471-478.