Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Launched by HOSPITALES UNIVERSITARIOS VIRGEN DEL ROCÍO · Aug 5, 2022
Trial Information
Current as of June 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
To date, the availability of highly-active antiretroviral drugs enables an efficient and persistent suppression of HIV replication. This, on the one hand, results in a considerably higher life expectancy and quality of life among persons living with HIV (PLWH) and, on the other hand, reduces the risk of viral transmission. Based on these advances, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has developed strategies aiming to end the HIV/AIDS epidemic by including preventive tools. With the aim to prevent the acquisition of HIV infection, recommendations for the use of post-expos...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • HIV negative as demonstrated by negative HIV serology as determined by EIA and Western-Blot.
- • Older than 18 years.
- • At high risk of acquiring HIV infection by sexual transmission.
- * MSM and transsexual persons who met at least two of the following criteria during the year prior to visit:
- • More than ten different sexual partners.
- • Anal sexual intercourse without using a condom.
- • Consumption of drugs in order to establish and/or maintain sexual relations without condom.
- • Administration of post-exposition prophylaxis in various occasions de profilaxis post- exposición en varias ocasiones.
- • At least one bacterial STI.
- • Women who prostitute themselves with no or irregular use of a condom. -Start daily or on-demand PrEP with TDF/FTC.
- • Give their written informed consent to participate in the cohort and its substudies.
- Exclusion Criteria:
- • Glomerular filtration rate \<60 ml/min.
- • For on-demand PrEP: diagnosis of chronic hepatitis B.
- • Allergic to TDF and/or FTC.
About Hospitales Universitarios Virgen Del Rocío
Hospitales Universitarios Virgen del Rocío is a leading healthcare institution in Spain, renowned for its commitment to excellence in patient care, medical research, and education. As a prominent clinical trial sponsor, it leverages its advanced facilities and a multidisciplinary team of experts to conduct innovative research aimed at improving therapeutic outcomes and advancing medical knowledge. The institution is dedicated to fostering collaboration between clinical practice and academic inquiry, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. With a focus on translating research findings into effective treatments, Hospitales Universitarios Virgen del Rocío plays a pivotal role in the advancement of healthcare and the well-being of patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seville, Andalusia, Spain
Patients applied
Trial Officials
Karin Neukam, PharmD, PhD
Study Director
Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla
César Sotomayor de la Piedra, MD
Principal Investigator
Hospitales Universitarios Virgen del Rocío
Marta Herrero Romero, MD, PhD
Principal Investigator
Hospitales Universitarios Virgen del Rocío
Alicia Gutiérrez Valencia, PharmD, PhD
Principal Investigator
Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla
Luis F López-Cortés, MD, PhD
Principal Investigator
Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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