Long-term follow-up of CAB LA for participants in the HPTN 083 and HPTN 084 studies.

CAB PrEP who are at risk of acquiring HIV. PALISADE was designed to continue the provision of long-acting Cabotegravir (CAB LA) as PrEP, for those patients who completed the original HPTN 083 study and wish to continue receiving this injectable PrEP modality every three months.

OPTImizing the Metabolic management of integrase inhibitor-based Antiretroviral Therapy (ART). This is a study to find ** new alternatives for the prevention** of metabolic alterations in patients receiving antiretroviral treatment with Integrase.

Inhibitors who have overweight or other metabolic complications. The study compares four treatment arms that include drugs to reduce cholesterol, such as Pitavastatin or Rosuvastatin/Ezetimibe, with or without the addition of a medication to control blood glucose levels, Dapagliflozin.

Observational study of severe acute respiratory infections (SARI) in hospitalized patients with immunocompromise.

This is a project from the STRIVE platform, aimed at characterizing clinical outcomes and describing the microbiology of patients with different forms of immunological disorders who require hospitalization due to respiratory infections.

A phase 3, randomized, active-controlled, open-label study to evaluate switching to a weekly oral islatravir/lenacapavir regimen in people with HIV-1 who are virologically suppressed on standard of care treatment. Current antiretroviral treatment includes once-daily tablet regimens.

The search for even more simplified schemes or for drugs administered via the parenteral route is aimed at simplifying treatment. ISLEN is a study that compares simple once-daily regimens with the weekly administration of the combination of islatravir plus lenacapavir.

A phase 2/3, randomized, open-label, multicenter, active-controlled, operationally efficient study to evaluate the safety and efficacy of bictegravir/lenacapavir versus a stable baseline regimen in virologically suppressed people with HIV-1 who are receiving stable complex treatment regimens.

The simplification of the current HIV infection treatment includes taking a single well-tolerated tablet per day. One of the challenges is being able to have the same tool for people who have received multiple treatments for years and who are receiving more complex regimens in daily doses or number of pills. ARTISTRY-2 is a Phase III study designed to answer this question. It involves evaluating the efficacy of the combination of Lenacapavir and Bictegravir in a single tablet in patients who are currently receiving complex regimens, comparing the strategy of continuing those schemes with the switch to a once-daily tablet of this combination.

An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Test the Safety and Efficacy of an Intravenous Hyperimmune Immune Globulin (hIVIG) for the Treatment of Adult Outpatients in the Initial Stages of COVID-19.

A Multicenter, Adaptive, Randomized, Controlled Platform Clinical Trial to Evaluate the Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Emerging Respiratory Infections.

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.

A multicenter, double-blind, randomized study to analyze the safety and efficacy of the
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.