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Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis

NCT05492565 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-09-22

No results posted yet for this study

Summary

Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other sexually transmitted diseases (STI).

In Southern Spain, the target population to receive PrEP are men who have sex with men (MSM) with a history of STI and who pursue high-risk sexual practices regarding the acquisition of HIV, including an elevate number of sex partners, no or inconsistent condom use and the use of specific recreational drugs in the context of sexual activity ("chemsex").

Despite the benefits of PrEP use, it must be taken into consideration that risk compensations that may facilitate the acquisition of other STI may occur, including a higher implementation of risk practices and an increase in the number of partners, which is made easy as various social networks designed for this purpose are available nowadays.

In order to better understand the benefit/drawback ratio, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.

Conditions

  • HIV Infection Primary
  • Hepatitis, Viral, Human
  • Sexually Transmitted Infections, Excluding HIV and Hepatitis

Interventions

DRUG

Tenofovir Disoproxil Fumarate 300 MG Oral Tablet

Pre-exposure prophylaxis with coformulated Tenofovir Disoproxil Fumarate 300mg/Emtricitabine 200mg oral QD to prevent HIV infection

Sponsors & Collaborators

  • Instituto de Biomedicina de Sevilla

    collaborator UNKNOWN

  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Principal Investigators

  • Karin Neukam, PharmD, PhD · Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

  • César Sotomayor de la Piedra, MD · Hospitales Universitarios Virgen del Rocío

  • Marta Herrero Romero, MD, PhD · Hospitales Universitarios Virgen del Rocío

  • Alicia Gutiérrez Valencia, PharmD, PhD · Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

  • Luis F López-Cortés, MD, PhD · Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492565 on ClinicalTrials.gov