Infectious Diseases
The Infectious Disease Department at St James’s hospital, has a long established research program. The CRF manages a number of both investigator-led and industry centred drug trials in conjunction with the GUIDe clinic.
| Study Name | Study Title | Study Type | Sponsor | Sponsor Type |
|---|---|---|---|---|
| PrEP | A Phase 3, Randomized, Double-blind study to evaluate the safety and efficacy of emtricitabin and tenofovir alfaenamide (F/AF) Fixed dose combination once daily for pre-exposure prophylaxis in men and transgender women who have sex with men and are at risk of HIV 1 infection | Clinical trial (NCT02842086) | Gilead | Commercial: Industry |
| Eurosida | EuroSIDA Prospective Observational Cohort Study on Clinical and Virological Outcome of European Patients Infected With HIV | Observational-non invasive | Rigshospitalet - University of Copenhagen | Non-commercial: Academic |
| Study Name | Study Title | Study Type | Sponsor | Sponsor Type |
|---|---|---|---|---|
| SOLAR study | A Phase IIIb, Randomized, Multicenter, Active-controlled,Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed | Clinical Trial (NCT04542070) (2020-002623-11) | GSK | Commercial: Industry |
| InoTerm ASTONISH | Efficacy, Safety and Tolerability of Nangibotide in Patients with Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study | Clinical Trial (NCT04055909) (2018-004827-36) | INOTERM S.A | Commercial: Industry |
| MK1439A-028 | Phase 2b, Double Blinded, Multicentre, Randomized study to assess the effect on central nervous system (CNS) toxicity of switching from Atripla (Efavirenz, tenofovir, emtricatabine) to MK-1439A (Doravine, Tenofovir, lamivudine) in virologically supressed subjects | Clinical Trial (NCT02652260) (2015-003617-18) | Merck | Commercial: Industry |
| PEACHI | PEACHI - A Phase 1 study to assess the safety and immunogenicity of prime boost immunisations with vaccine candidates AdCh3NSmut1 and MVA-Nsmut in HIV-1 seropositive HCV-uninfected adults on antiretroviral therapy (ART) | Clinical Trial (NCT02568332) | University of Oxford | Non-commercial: Academic |
| Gilead | A phase 3b, Randomized, Double Blind, swithc study to evaluate F/TAF in HIV-1 infected Subjects who are virologically suppressed on regimens containing ABC/3TC | Clinical Trial (NCT02469246) | Gilead | Commercial: Industry |
| COGHIV | The effects of a 16 week aerobic exercise programme on cognitive function in people living with HIV: A Radnomised Controlled Trial | Observational-non invasive | N/A | Non-commercial: Academic |
| COGIMP | The Inflammatory Neurodegenerative Continuum in HIV Related Cognitive Impairment. Longitudinal Follow up of Cognitive Impairment in a Well Characterized Cohort of HIV Positive Patients | Observational-non invasive | N/A | Non-commercial: Academic |