Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Официальное название

Clinical Study to Investigate the Effect of Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Обзор

Bacterial sexually transmitted infections (STIs) have been steadily increasing in gay, bisexual, and other men who have sex with men (MSM) over the past 2 decades. While that trend started prior to the introduction of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in 2012, HIV PrEP has been associated with increases in sexual contacts and decreases in condom use with an resultant acceleration in the increase of bacterial STIs such as gonorrhea, syphilis, and chlamydia.

Подробное описание

Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated. It is rapidly and almost completely absorbed after oral administration. First introduced commercially in the 1960s, doxycycline has been used by millions to manage acne and as primary prophylaxis for scrub typhus, leptospirosis, malaria, and Lyme disease. There are anecdotal reports of doxycycline used for syphilis prophylaxis among US and Australian military personnel during the Vietnam War. Doxycycline is a first-line agent for treatment of chlamydia and an alternative regimen for syphilis.An open-label extension of the French national HIV research agency (France Recherche Nord \& sud Sida-hiv hépatites \[ANRS\]) Intervention Préventive de l'Exposition aux Risques avec et pour les Gays (IPERGAY) HIV-prevention study continued participant access to HIV PrEP and examined doxycycline postexposure prophylaxis (Doxy PEP) in MSM and transgender women without HIV \[17\]. Participants (n = 232) were randomly assigned 1:1 to the intervention-doxycycline 200 mg within 24-72 hours of condomless sexual encounters up to 3 times per week-or to no prophylaxis. Those taking Doxy PEP had lower STI incidence (hazard ratio, 0.57; P = .014). Chlamydia trachomatis and syphilis diagnoses were significantly lower in the intervention arm, with a relative reduction of 70-73% in the intention-to-treat analysis.

Вмешательства

• Препарат Doxycyclin
  Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated
• Препарат Pentoxifylline
  Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity
• Препарат Nitazoxanide 500Mg Oral Tablet
  Nitazoxanide is a broad-spectrum antiparasitic and broad-spectrum antiviral medication that is used in medicine for the treatment of various helminthic, protozoal, and viral infections

Первичные конечные точки

• treatment of chylamdia in sexually active men [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Individuals aged > 18 years were eligible for participation if they had a diagnosis of untreated gonorrhea and chlamydia. The untreated status was defined as no antibiotic taken in the previous 28 days to treat gonorrhea and chlamydia.

Критерии исключения

• known contraindications or hypersensitivity to doxycycline, pentoxifylline, and nitazoxanide.

gonorrhea with complications, such as pelvic inflammatory disease or epididymo-orchitis significant renal failure or hepatic failure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05897034 · 3568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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