Active Studies

ENSEMBLE

VAC31518COV3001; fase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

This study is being conducted under the sponsorship of Janssen (Janssen Vaccines & Prevention B.V) in collaboration with Operation Warp Speed (OWS), which also encompasses the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the COVID-19 Prevention Trials Network (COVPN)

The primary objective of this study is to demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults. Ad26.COV2.S (previously known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein.

HPTN 083

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.

COHIVE

Evaluation of COVID-19 HIV Outcomes in Limited Resource Contexts - “COVID-19 Outcomes in HIV Evaluation in Resource Limited Settings” (Short title). COHIVE - COVID-19 in People Living with HIV: Assessment of Risk Factors and Outcomes in Resource-Limited Settings - A Combined Substudy of ADVANCE, D2EFT, DolPHIN2, and NAMSAL.

Study sites:
Argentina:

General hospital of acute J. M. Ramos Mejía (CABA).

Brazil:

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.

MOSAICO

Protocol VAC89220HPX3002

Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of a heterologous vaccination regime with Ad26.Mos4.HIV and the combination of adjuvanted Clate C gp140 and Mosaic gp140 to prevent infection by HIV-1 among cisgender men and transgender individuals who have sex with cisgender men and / or transgender individuals.
Summary of study: The objective of this study is to demonstrate the efficacy of a heterologous vaccination regime for the prevention of human immunodeficiency virus type 1 (HIV-1) infection consisting of Ad26.Mos4.HIV and a combination of glycoprotein (gp) from Clade C 140 and Mosaic gp140 (gp140 Mos), adjuvated with aluminum phosphate. The study population will include healthy adults who are considered to be at higher risk of acquiring HIV-1 infection. The expected number is 3,800 participants, consisting of HIV-1 uninfected persons, specifically cisgender men and transgender individuals who have sex with cisgender men and / or transgender individuals, aged ≥ 18 to ≤60 years, will be randomized in a proportion 1: 1 to receive study vaccine or placebo.

ITAC

Multicenter, adaptive, randomized, double-blind, placebo-controlled international trial evaluating the safety, tolerance, and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin for the treatment of hospitalized adult patients at the onset of clinical progression of COVID-19.

DEFT

A phase IIIB/IV randomised open-label trial to compare dolutegravir + pharmaco-enhanced darunavir versus recommended standard of care antiretroviral regimens in patients with HIV infection who have failed recommended first line therapy.

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:

Argentina:

General hospital of acute J. M. Ramos Mejía (CABA).
CAICI (Rosario).
Paroissien Hospital (Province of Buenos Aires).
San Juan de Dios Hospital (La Plata).

Brazil:

INI - Fiocruz (Rio de Janeiro)

Chile:

Arriarán Foundation (Santiago de Chile).

Colombia:

High Complexity Scientific Assistance SAS (Bogota DC)

Mexico:

INCMNSZ (Mexico City).
Civil Hospital of Guadalajara (Guadalajara).
Morales vargas Research Center (Leon).

START

Strategic Timing of AntiRetroviral Treatment. Evaluation of the strategic timing to start antiretroviral treatment (ART) in HIV-positive patients. The objective of the study is to determine whether HIV-positive patients benefit from early antiretroviral therapy (before CD4 drops to less than 500 cells/mm³) Countries: 35 totally, and 5 in Latin America. Sites: 222 totally, and 22 in Latin America. Patients: 4688 totally, and 1174 in Latin America.
http://insight.ccbr.umn.edu/start

FLU003 PLUS

An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses. Respiratory Virus Hospitalization Study (FLU 003 Plus). It is a prospective study to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. Specific objectives related to influenza virus infection are to determine the percentage of participants who die or develop other adverse outcomes following hospitalization for influenza, to obtain information on risk factors for mortality and other adverse outcomes, and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment. Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections Countries: 16 totally, and 2 in Latin America. Sites: 67 totally, and 11 in Latin America. Patients: 2765 totally, and 294 in Latin America.
https://insight.ccbr.umn.edu/flu003/

ACTIV-01

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.

COVPN 5001

Prospective study of acute immune responses to SARS-CoV-2 infection.

The main objective of the study is to generate standardized data sets that characterize the quality, magnitude and kinetics of humoral immune responses to a SARS-CoV-2 infection in asymptomatic and symptomatic participants (hospitalized and non-hospitalized) who present a variety of clinical outcomes to prepare similar evaluations during trials of immune prevention strategies and to characterize innate and cellular immune responses to a SARS-CoV-2 infection during such an infection in asymptomatic and acutely symptomatic participants (hospitalized and not hospitalized).

TELEMEDICINE

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.

TICO

Therapeutics for Inpatients with COVID-19 (TICO). A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19.

TICO is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression. Trials within this protocol will be phase III, adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of this protocol.

Active Studies

VAC31518COV3001; fase 3

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