Fundación Huésped

Experience

25 years carrying clinical trials in HIV drug, big experience in other trials, pragmatic trials, implementation trials coordinated in Argentina and Bolivia.
We perform clinical trials since 1994, with more than 3000 patients enrolled.
We usually do pharma trials, specially focused to HIV and other IDs.
However, we did a study about adyuvants in neisseria vaccine.
we have plenty access to general population and HIV participants.

Disease areas

• Cancer
• Chagas
• Helminths
• HIV
• Maternal Health
• Sexually Transmitted Diseases (STDs)
• TB
• Zika

Fundación Huésped, Argentina The clinical procedures for this project will be carried out at Fundación Huésped Clinical Research Offices, all the administrative procedures, regulatory work, data compilation and quality control will be done at UEM-Huesped, laboratory procedures at Laboratory Centro Médico Huésped. Fundación Huésped: is located in Buenos Aires City, in the neighborhood of Almagro. The office is accessible from several locations and includes 3 buildings (Clinical Research Offices, UEM-Fundación Huésped, and Laboratory). Clinical Research Area at Fundación Huésped: FH has a long history of clinical research, with more than 2800 patients enrolled in clinical trials, a cohort of 1500 active patients, and 150 patients on follow-up in clinical protocols. The FH maintains compliance with local and nationwide regulatory requirements, and meets the required criteria for the routine care of patients and for clinical protocols from phase 1b to IV. The FH Research Agenda for 2016-2018 includes: new ART treatments and strategies, PreP studies among high risk populations, ART studies in transgender women (TGW), ART cohort studies (CCAsanet Project NIH 2-U01-AI069923), cohorts of patients with acute HIV infection, HIV and cascade of care projects among vulnerable populations, treatment as prevention and other biomedical prevention strategies, adherence and retention programs (COPA Study, Grant # 1R34MH097609-01), and translational research in AIDS Malignancies (NCI-NIAID, 2P30AI073961-06). FH has been also studying: human papillomavirus (HPV) infection and HPV lesions prevalence in HIV women, HIV men who have sex with men and TGW with funds from the National Cancer Institute (Argentina), barriers for HIV care, HIV testing in Argentina, and conducting advocacy and technical assistance activities for early linkage to care. FH was recently incorporated as a HPTN site for the protocol HPTN083 that will be testing cabotegravir vs. Truvada among MSM and TGW. Omar Sued, PhD, MD, MSc, a certified Internal Medicine Specialist and Infectious Diseases Specialist, is the Clinical Research Director and is responsible for the overall performance of the area. He has been involved in the provision of primary HIV care and HIV management since 1997. He has a strong background in clinical management, clinical research, and public health. As Director of Clinical Research at FH, he is involved in the design, planning and oversight of all research activities at FH, supervising a team of 26 individuals. He has specific allocated time for research and a team of medical doctors and administrative personnel for assisting him in the daily activities. He will be responsible for ensuring compliance with the financial, administrative, and programmatic aspects of the project; for conducting the research in an ethical manner; and for compliance with all laws, policies, guidelines, and local and international regulatory requirements. Headquarter and Clinical Research Offices are located at Angel Peluffo 3932, C1202ABB, Buenos Aires City. FH Headquarter is located in a 4-story building where the 5 FH departments are located: Communications & Resource Development, Epidemiology and Prevention Area, Youth Area, Community Services Area and Clinical Research Area, as well as the Central Administration, the Director’s Office, and the Bioethics Committee. Clinical Research uses two floors, totaling 34% of the total surface. On the ground floor, the area has 1 waiting room, 1 reception room with 2 administrative positions, the Area Director’s office, the office for medical staff with one fully equipped working station for each physician, and 4 fully equipped examination rooms where informed consent, assessment and medical evaluations are conducted, ensuring confidentiality. In the patient rooms, blood can be collected to be sent to the central laboratory. Other activities in the same building includes the free legal advice service (3 lawyers provide counseling and legal advice for HIV related legal problems), the free mental health program (5 psychologist provides counseling and psychotherapy to HIV patients), the work counseling service (that provide orientation for work seekers) and the voluntary rapid test center that provides 1400 free HIV test annually. FH has a meeting room that holds 50 people, and other meeting room with capacity for 10 people, that is used for investigator meetings and training sessions. The rooms are equipped with audiovisual technology that allow teleconferences through a toll free line, and web based teleconferences. Other rooms are dedicated to file archive research documents, with double-locker system where clinical records are organized per protocol and per year and are kept per local regulations for a minimum of 15 years. The pharmacy has a biosafety cabinet A2, dedicated fax, printer, and computer, 2 refrigerators with freezer (one for backup) and electronic temperature sensor and 2 air conditioners (one for back-up). The building has 4 phone lines and other 2 dedicated 24/7 to fax sending and reception, 24-hour high speed internet access and a backup internet provider. A secure intranet is in place, allowing access to personal documents from any computer after secure login. Shared space for clinical research and email and personal schedules access through webmail allow easy communication. All this information is backed-up at the end of each working day. An owned and operated car service for patients with reduced mobility, or for moving important documents and materials to and from the institution is available from 6 AM to 10 PM. FH has contracts with an ambulance emergency service, a 24-hr cab company, a biological and medical disposal waste service, and an oxygen supply company, in addition to general maintenance to ensure periodic calibrations, continued power and water supply and internet service. UEM-Fundacion Huésped is the Data Management Center and Quality Control Unit: This office is located at Medrano 70, C1178ABB, Buenos Aires City. It comprises a two-floor office. The 4th floor is dedicated to data management, epidemiological studies and social research, is equipped with 5 workstation with computers that have access to internet and intranet, printer, telephone lines, 6 workstations in two rooms with computers that have access to internet and intranet, printer, 4 telephone lines and fax. A 180-foot square storage area is available and protected with double key. The 5th floor is dedicated to the Monitoring Unit and has a meeting room that holds 15 people equipped with a flat screen, a two workstation for the Unit Coordinators, and a big room with place for 8 people (3 monitor, 2 data entry, 1 database administrator, 1 project manager, and a regulatory coordinator). The place have numerous cabinets and secured storage areas. Laboratory: The Central Laboratory is located Centro Médico Huésped at Gascón Street 79, C1181ABA, Buenos Aires City, at a 3-minute walking distance from FH headquarter. All of the laboratory procedures to be employed as part of this project are to be conducted in this location. It is a 3-floor building, with reception, waiting area, phlebotomist room, laboratory, storage rooms, and 3 patient examination rooms fully equipped (desk, personal computer, and examination table, standing weight scale, blood pressure monitor and thermometer). The laboratory is capable of intake, processing and storing samples (blood, PBMCs, semen, sputum, urine and other specimens), and the personnel is trained and certified in handling and shipping infectious samples according to GLP and IATA regulations. Equipment includes several -20°C and -70°C freezers, liquid hydrogen, dry ice supply, and a refrigerated aerosol-contained centrifuge, laminar flow hood, ViCell counter, computer and a sample labeling system. The laboratory has recently updated virological equipment, and performs all the required laboratory procedures for HIV and other infectious disease care. Various viral load techniques are in place (Abbott, Taqman, b-DNA), as well as flow cytometry (Becton-Dickinson) and resistance testing (TrueGene, Siemens). Serum samples from all participants will be stored for future research endeavors at this laboratory. Through its lab, the Centre provides monitoring and routine HIV/AIDS laboratory services, including genotypic and phenotypic drug resistance and serologies. Routine clinical tests include plasma viral load, CD4 cell counts, and blood chemistry and hematology, Ficoll separation, cell and plasma storage, etc. Fundación Huésped Performance and Experience: FH is a nationally and internationally renowned center for AIDS research. We participate in scientific studies of our own design and also in collaboration with other institutions, national and international cohort studies and pharmaceutical phase Ib-II-III and IV studies. FH has successfully passed inspections and audits from the National Administration of Drugs, Food and Medical Technology (ANMAT) and international organizations, including the Food and Drugs Administration (FDA) of the United States. Currently FH is part of the IMPAACT and the HPTN networks. Ability to enroll and retain in clinical protocols: Since 1996, FH has carried out more than 146 clinical trials, screened 3,324 patients, and included 2,398 participants. Most of these studies were new drugs studies (64, 58 for adults and 6 for children), 9 for new antifungals, 4 for immunotherapies, among other topics including cost, lipodystrophy treatment, structured treatment interruption studies or nutritional studies. All these studies achieved a retention rate >95% at 48 weeks, which in many cases justified roll-over studies. The table below shows details for studies carried out in the last 10 years. Not included in the table, during the 1996 - 2005 period, FH carried 72 protocols, in which 1,651 patients were screened and 1,347 started an investigational intervention. Most of these studies were evaluation of efficacy of ARV drugs, but also, there were PK studies, antifungal, therapeutic vaccines studies, IL2, hydroxyurea or other immunological compounds, pediatric studies, and different treatment strategies. The table below describes the pharmacological studies carried out at FH since 2007. Cohort studies, totalizing more than 4,000 patients are not including here. We should mention the Argentinean Group of HIV Seroconversion Cohort (with more than 200 individuals) the Argentinean representation for the CCAsanet Cohort (contributing with 4,000 clinical records to the Latin American Cohort. Fundacion Huesped has an extensive network of more than 700 referral HIV doctors from the country that ensure rapid access to patients. In addition, together with Hospital Fernández, FH has created the Grupo Argentino de Seroconversion that enrolled more than 200 HIV seroconverters since 2008. In addition, FH carried out 25 Investigator Initiative Studies, among them the GARDEL and the PADDLE studies.