Active Studies
STRIVE is a platform that will develop different studies in the medium and long term aimed at new treatments and treatment strategies for different Emerging Diseases.
STRIVE Trial 1. Ensitrelvir
A randomized, double-blind, placebo-controlled study to analyze the efficacy and safety of Ensitrelvir in patients hospitalized for COVID-19.
STRIVE Trial 2. Abatacept
A randomized, double-blind, Placebo-controlled study to analyze the efficacy and safety of Abatacept in patients hospitalized for COVID-19.
administration of two annual subcutaneous doses of Lenacapavir vs. Tenofovir/FTC, in cis men, trans women, trans men and non-binary people, over 16 years of age, who have sex with men and at risk of acquiring HIV infection.
A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men.
Summary of study: HPTN 083 is a multi-site, double blind, two-arm, randomized (1:1), controlled non-inferiority trial of the efficacy of CAB LA compared to daily oral tenofovir disoproxyl fumarate (TDF)/emtricitabine (FTC) for HIV prevention. The purpose of this study is prove efficacy of CAB LA compared to daily oral tenofovir disoproxyl fumarate (TDF)/emtricitabine (FTC) for HIV prevention to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). The study population is HIV-uninfected MSM and TGW at risk for acquiring HIV infection, ages 18 or older, approximately 5000, 2500 per arm. The duration of the study is approximately 7.5 years.
Study sites:
Argentina:
- General hospital of acute J. M. Ramos Mejía (CABA).
- INI - Fiocruz (Rio de Janeiro)
Summary of the study: The COHIVE study is a substudy of 4 main studies (ADVANCE, D2EFT, DolPHIN2 and NAMSAL) that seeks to describe the clinical characteristics and evolution of symptomatic COVID-19 in people living with HIV (PLHIV), described in general and by factors of HIV and comorbid disease, including reproductive status. Furthermore, it will allow determining the seroprevalence for COVID-19 in all the participants of the main study at the first feasible moment after the control of the epidemic in the country (regardless of the existence of symptomatic COVID-19 infection. The existence of established studies on HIV Therapies (ADVANCE, D2EFT, DolPHIN2 and NAMSAL) provides a unique opportunity to gather shared information on the incidence and outcomes of PLHIV in a variety of clinical settings (including first and second line HIV therapies) and a global variety from unique research centers. This study provides an immediate impact on public health, providing critical information for a key vulnerable population in this evolving crisis, and possibly accelerating the development of widely applicable therapies. It also provides an impact on the health system, supporting the availability of tests and releasing test kits and equipment for personal protection and for other uses, as well as reinforcing the provision of test kits in this context.
Summary of the study: The D2EFT study attempts to determine whether any of the simple regimens of DTG + darunavir/ritonavir (DRV/r) and DTG + 2NRTI aren´t inferior to the current ART regime (SOC) recommended by the WHO and not between them. If either regime is noninferior, the guidelines could then change, implying that these findings quickly translate into the treatment of millions of people in resource-limited settings. Each of these two simplified approaches investigated in this study offers a realistic opportunity for co-formulation into a single tablet, administered once daily and prescribed without the need for a (genotypic) HIV drug resistance test. These characteristics would lead to a public health approach (red tablet - first line, blue tablet - second line) for the management of HIV disease in resource-limited settings.
Study sites:
- General hospital of acute J. M. Ramos Mejía (CABA).
- CAICI (Rosario).
- Paroissien Hospital (Province of Buenos Aires).
- San Juan de Dios Hospital (La Plata).
- INI - Fiocruz (Rio de Janeiro)
- Arriarán Foundation (Santiago de Chile).
- High Complexity Scientific Assistance SAS (Bogota DC)
- INCMNSZ (Mexico City).
- Civil Hospital of Guadalajara (Guadalajara).
- Morales vargas Research Center (Leon).
Randomized master protocol for the treatment of COVID-19 with immunomodulators.
ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents as treatment for moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). The objectives of the research are to evaluate each agent in relation to the speed of recovery, mortality, severity of the disease and use of hospital resources. Each agent will be evaluated as a therapeutic adjunct to standard treatment (SoC) when used in local clinics, including remdesivir (supplied). The SoC may change during the course of the study based on other research findings. Comparisons between agents is not an objective of the investigation. The study population corresponds to moderately to severely ill patients infected with the 2019 coronavirus disease virus (COVID-19). Recruitment will focus on patients already hospitalized for the treatment of COVID-19 infection as well as patients who are being treated for COVID-19 infection in Emergency Rooms while awaiting admission to the hospital. Patients who are in and out of ICUs are included in the study population.
https://insight.ccbr.umn.edu/flu003/
Delivery of HIV care through telemedicine in public hospitals in Buenos Aires, Argentina during COVID-19 pandemic: implementation research.
This is a Prospective observational study design using mixed methods with a hybrid type-3 design using RE-AIM framework. The goals of this study are to use Implementation Facilitation to implement the telemedicine intervention in Buenos Aires City public hospital network in the context of COVID-19 pandemic and to generate the scientific evidence needed to disseminate VCT adapted to HIV care in public hospitals. Because this hybrid type 3 study.