Closed Studies
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.
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).
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
http://insight.ccbr.umn.edu/start
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.
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.
Study News
The previously planned analysis of the study results clearly shows that the number of people who have become infected with HIV is very similar in both arms of the study (vaccine or placebo), therefore it has NOT been possible to demonstrate the efficacy of this vaccine to prevent HIV infection.
For this reason, the independent Committee that periodically evaluates the data of the study (DSMB) has recommended us, the investigators and the sponsor, to stop the study, since these findings are consistent and it is not possible that they will be modified with more follow-up time. On the other hand, the vaccine proved to be safe, that is, it was not associated with significant adverse effects.
Once again, we want to thank the commitment and effort of the participants in this research, our respect and admiration for them, together with our commitment to continue monitoring them if they consider it so. A special recognition to the Community team, to the ClinSex and Emerging Diseases team of the JM Ramos Mejia Hospital; and each one of the members of the CICAL team, for their commitment and hard work of excellence to make this study possible.
Official communiqués of HVTN network and Johnson & Johnson:
TB/HIV
Tuberculosis in HIV-positive patients: An international prospective observational study. It is a prospective cohort study in HIV-positive patients diagnosed with tuberculosis. The aim is to study prospectively the clinical long-term prognosis of HIV-positive patients with active TB in Europe and Latin America, the variations over time and regional differences. Countries: 19 totally and 3 in Latin America. Sites: 49 totally and 13 in Latin America. Patients: 1500 totally and 255 in Latin America.
Estudo de Genômica INSIGHT
(INSIGHT Protocol Nº 004. A substudy of qualifying INSIGHT studies). The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies. Countries: 10 totally, and 2 in Latin America. Sites: 63 totally, and 8 in Latin America. Patients: 1489 totally, and 222 in Latin America
FLU002 Plus
An international observational study to characterize adults with influenza or other targeted respiratory viruses. Respiratory Virus Outpatient Study (FLU 002 Plus) It is a prospective study that describes participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; 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: 18 totally, and 2 in Latin America. Sites: 63 totally, and 15 in Latin America. Patients: 11414 totally, and 3250 in Latin America.
https://insight.ccbr.umn.edu/flu002/
https://insight.ccbr.umn.edu/flu002/
IRC003
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications The overall objective of the study is to evaluate the antiviral efficacy of the combination antivirals (oseltamivir/amantadine/ribavirin) as compared to oseltamivir alone in the treatment of at-risk subjects with confirmed influenza infection Countries: 4 totally, and 2 in Latin America. Sites: 46 totally, and 11 in Latin America. Patients: 111 totally, and 15 in Latin America.
https://nirc.s-3.com/argentina003/
https://nirc.s-3.com/argentina003/
MARCH
Maraviroc Switch Collaborative Study: The main aim of this study is to investigate whether switching maraviroc, in combination with either RTI or PI/r, is as good at keeping the amount of HIV in patients’ blood undetectable (below the level of the standard tests in the laboratory) as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc result in an improvement in some of the side effects that can be seen when people take combination therapy including RTI and PI/r. This is an international, multicentre trial enrolling 560 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. Countries: 13 totally, and 3 in Latin America. Sites: 58 totally, and 11 in Latin America. Patients: 396 totally, and 180 in Latin America.
http://www.kirby.unsw.edu.au/projects/march-study-maraviroc-switch-collaborative-study
http://www.kirby.unsw.edu.au/projects/march-study-maraviroc-switch-collaborative-study
IRC004
A randomized double-blind study comparing Oseltamivir versus Placebo for the treatment of Influenza in low risk adults. This randomized double-blind study will assess evaluate whether oseltamivir modifies viral shedding in an ambulatory population with uncomplicated influenza. This study is also designed to explore the relationship between virologic effects and clinical effects, effects on pro-inflammatory mediators, and to start understanding if improvements to virologic shedding correlate with improvements in clinical outcomes. The overall objective of the study is to evaluate the antiviral efficacy of oseltamivir compared to placebo in the treatment of subjects with confirmed influenza infection. Sites: 40 totally, 5 in Latin America. Patients: 179 totally, 13 in Latin America.
https://nirc.s-3.com/argentina004/
https://nirc.s-3.com/argentina004/
SECOND LINE
A randomised open-label study comparing the safety and efficacy of a ritonavir-boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir-boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy. Countries: 14 totally and 4 in Latin America. Sites: 37 totally and 16 in Latin America. Patients: 558 totally, and 114 in Latin America.
http://www.kirby.unsw.edu.au/projects/second-line-study
http://www.kirby.unsw.edu.au/projects/second-line-study
ENCORE
Evaluation of Novel Concepts in Optimization of antiRetroviralEfficacy. International, multicentre, randomised double-blind placebo-controlled trial to compare the safety and effectiveness of a reduced dose of HIV therapy efavirenz, or EFV (400mg compared to 600mg)in combination with two other standard ART drugs in HIV-positive people who have not previously taken HIV therapy Countries: 13 totally and 2 in Latien America. Sites: 38 totally and 4 in Latin America. Patients: 636 totally, and 121 in Latin America.
http://www.kirby.unsw.edu.au/news/encore-international-study-funded-gates-foundation
http://www.kirby.unsw.edu.au/news/encore-international-study-funded-gates-foundation
SMART
A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy
Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial.SMART Study Group, El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Ann Intern Med. 2008 Sep 2;149(5):289-99.
CD4+ count-guided interruption of antiretroviral treatment.Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fätkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. N Engl J Med. 2006 Nov 30;355(22):2283-96.
Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial.SMART Study Group, El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Ann Intern Med. 2008 Sep 2;149(5):289-99.
CD4+ count-guided interruption of antiretroviral treatment.Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fätkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. N Engl J Med. 2006 Nov 30;355(22):2283-96.
SILCAAT
Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts. A phase III multicenter randomized study of the biological and clinical efficacy of subcutaneous recombinant, human interleukin-2 in HIV-infected patients with low CD4+ counts under active antiretroviral therapy.
Interleukin-2 therapy in patients with HIV infection. INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. N Engl J Med. 2009 Oct 15;361(16):1548-59.
Interleukin-2 therapy in patients with HIV infection. INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. N Engl J Med. 2009 Oct 15;361(16):1548-59.
ALTAIR
A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection.
Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Clin Infect Dis. 2010 Oct 1;51(7):855-64.
Efavirenz versus boosted atazanavir or zidovudine and abacavir in antiretroviral treatment-naive, HIV-infected subjects: week 48 data from the Altair study. Puls RL, Srasuebkul P, Petoumenos K, Boesecke C, Duncombe C, Belloso WH, Molina JM, Li L, Avihingsanon A, Gazzard B, Cooper DA, Emery S; Altair Study Group. Clin Infect Dis. 2010 Oct 1;51(7):855-64.
ESPRIT
A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 (Proleukin®) in Patients With HIV-1 Infection and CD4+ Cell Counts = 300/mm3. The purpose of this study is to compare the effects of subcutaneous recombinant interleukin-2 (SC rIL-2) and no SC rIL-2 on disease progression and death over a 5-year follow-up period in patients with HIV-1 infection and absolute CD4+ cell counts of = 300/mm3 who are taking combination antiretroviral therapy.
A randomized, controlled, phase II trial comparing escalating doses of subcutaneous interleukin-2 plus antiretrovirals versus antiretrovirals alone in human immunodeficiency virus-infected patients with CD4+ cell counts >/=350/mm3. Losso MH, Belloso WH, Emery S, Benetucci JA, Cahn PE, Lasala MC, Lopardo G, Salomon H, Saracco M, Nelson E, Law MG, Davey RT, Allende MC, Lane HC. J Infect Dis. 2000 May;181(5):1614-21. Epub 2000 May 15.
Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT).Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miró JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. HIV Med. 2011 Apr;12(4):219-27.
Interleukin-2 therapy in patients with HIV infection. INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. N Engl J Med. 2009 Oct 15;361(16):1548-59.
A randomized, controlled, phase II trial comparing escalating doses of subcutaneous interleukin-2 plus antiretrovirals versus antiretrovirals alone in human immunodeficiency virus-infected patients with CD4+ cell counts >/=350/mm3. Losso MH, Belloso WH, Emery S, Benetucci JA, Cahn PE, Lasala MC, Lopardo G, Salomon H, Saracco M, Nelson E, Law MG, Davey RT, Allende MC, Lane HC. J Infect Dis. 2000 May;181(5):1614-21. Epub 2000 May 15.
Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT).Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miró JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. HIV Med. 2011 Apr;12(4):219-27.
Interleukin-2 therapy in patients with HIV infection. INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. N Engl J Med. 2009 Oct 15;361(16):1548-59.
MAGNIFICENT
Contribution of Genetic Background, Traditional Risk Factors, and HIV-Related Factors to Coronary Artery Disease Events in HIV-Positive Persons.
Rotger M, Glass TR, Junier T y col. Contribution of genetic background, traditional risk factors and HIV-related factors to coronary artery disease events in HIV-positive persons. Clin Infect Dis. 2013; 57(1):112-21.
Rotger M, Glass TR, Junier T y col. Contribution of genetic background, traditional risk factors and HIV-related factors to coronary artery disease events in HIV-positive persons. Clin Infect Dis. 2013; 57(1):112-21.
STALWART
A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) with and without Concomitant Antiretroviral Therapy in Patients with HIV-1 Infection and CD4+ Cell Counts = 300/mm3.
Markowitz N, Lopardo G, Wentworth D, Gey D, Babiker A, Fox L, Tavel J; STALWART Study Group. Long-term effects of intermittent IL-2 in HIV infection: extended follow up of the INSIGHT STALWART Study. PloS One 2012;7(10):e47506.
Tavel JA; INSIGHT STALWART Study Group, Babiker A, Fox L, Gey D, Lopardo G, Markowitz N, Paton N, Wentworth D, Wyman N. Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. PLoS One. 2010 Feb 23;5(2):e9334.
Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.Tavel JA; INSIGHT STALWART Study Group,
Babiker A, Fox L, Gey D, Lopardo G, Markowitz N, Paton N, Wentworth D, Wyman N. PLoS One. 2010 Feb 23;5(2):e9334.
Markowitz N, Lopardo G, Wentworth D, Gey D, Babiker A, Fox L, Tavel J; STALWART Study Group. Long-term effects of intermittent IL-2 in HIV infection: extended follow up of the INSIGHT STALWART Study. PloS One 2012;7(10):e47506.
Tavel JA; INSIGHT STALWART Study Group, Babiker A, Fox L, Gey D, Lopardo G, Markowitz N, Paton N, Wentworth D, Wyman N. Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study. PLoS One. 2010 Feb 23;5(2):e9334.
Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.Tavel JA; INSIGHT STALWART Study Group,
Babiker A, Fox L, Gey D, Lopardo G, Markowitz N, Paton N, Wentworth D, Wyman N. PLoS One. 2010 Feb 23;5(2):e9334.
TAI
Individualized Antiretroviral Treatment (Self-Founded Studies)
This is an own-initiative academic study which has obtained a grant from the Argentine National Agency for Scientific and Technological Promotion. It is a multicenter study with the objective of evaluating the use of the pharmacological information (pharmacogenomics + therapeutic monitoring of drugs in plasma) applied to the efficacy and safety of first-line antiretroviral treatments based on efavirenz or atazanavir.LATINA
LATINA (Self-Founded Studies)
Latin American cohort of people with HIV/AIDS. LATINA is a multinational initiative to establish a regional collaboration for the collection and analysis of epidemiological and clinical data of high quality associated with people living with HIV/AIDS. This project includes the systematic collection, transfer, receipt, verification, analysis and presentation of data that can generate genuine knowledge about particular aspects of the HIV epidemic in Latin America. LATINA Cohort is divided into two main projects, the Retrospective Cohort, including epidemiological and clinical data of patients followed between 1997 and 2009 in health sites of the participating countries, and the Prospective Cohort, now open to recruitment among the participating sites. Retrospective LATINA presented results of their analysis on international Conferences of HIV/AIDS in Mexico in 2008, Cape Town (South Africa) in 2009 and published in HIV Medicine in 2010. Prospective LATINA is currently open for enrollment of patients in the participating sites, and it is also open to the incorporation of new sites and countries in the region. Countries: 4 in Latin America. Sites: 14 in Latin America. Patients: around 1600 in Latin America.
LATINA prospective cohort was participate with a poster at “Sociedad Argentina de Infectología 2016”, HIV & HEP AMERICAS 2016 adding a new publication in the Journal of the International AIDS Society. See poster
Newsletter Nº 1 - March 2014
Newsletter Nº 2 - August 2014
Newsletter Nº 3 - March 2015
Newsletter Nº 4 - August 2016
Protocol
Concept Sheet
Variables collected in the eCRF
C.diff
C.diff is an international observational study to estimate the 90-day response rates for several different antibiotic treatments for C. difficile infections in a cohort of solid organ and hematopoietic stem cell transplant patients. This includes treatment success, recurrence, and complications. Secondary objectives are to describe the clinical characteristics of C. difficile infections and to assess risk factors for outcomes over a 90-day follow-up period.
https://insight.ccbr.umn.edu/i07/
https://insight.ccbr.umn.edu/i07/
FLU IVG
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study. The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (IVIG) in individuals with influenza A or B is to determine whether, when added to standard of care (SOC) treatment, administration of IVIG is superior to placebo in terms of reducing disease severity and duration. It is expected to enroll approximately 320 patients in 40 sites in United States. Europe, Latin America and Australia. Patients: 78 totally, and 2 in Latin America.
https://insight.ccbr.umn.edu/i06/
https://insight.ccbr.umn.edu/i06/