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

Tanta University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Sexually Transmitted Diseases

Treatments: Drug: Doxycyclin; Drug: Pentoxifylline; Drug: Nitazoxanide 500Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05897034

3568

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

control group

Active Comparator group

Description:

This group will take doxycycline 100 mg twice daily

Treatment:

Drug: Doxycyclin

Comparative group

Active Comparator group

Description:

This group will take doxycycline 100 mg twice daily, pentoxifylline 400 mg twice daily, and nitazoxanide 500 mg twice daily.

Treatment:

Drug: Doxycyclin

Drug: Nitazoxanide 500Mg Oral Tablet

Drug: Pentoxifylline