Tenofovir Disoproxil Fumarate 300 MG Oral Tablet: Pre-exposure prophylaxis with coformulated Tenofovir Disoproxil Fumarate 300mg/Emtricitabine 200mg oral QD to prevent HIV infection
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change from baseline proportion of PrEP users with STI-4c at one year — Baseline through one year Analysis of a change in the proportion of persons that present with infection by at least one of the following four common sexually transmitted pathogens (STI-4c): Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis and/or Mycoplasma genitalium.
Incidence of primary HIV infection — Through study completion (an average 3 years) Determination of the incidence of primary HIV infections during PrEP use
Trial sites (1)
Facility
City
Region
Status
Virgen del Rocío University Hospital
Seville
Andalusia
More Hospitales Universitarios Virgen del Rocío trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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