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

NCT ID: NCT05897034

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2028-06-20

Brief Summary

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.

Detailed 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.

Conditions

Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

This group will take doxycycline 100 mg twice daily

Group Type: ACTIVE_COMPARATOR

Doxycyclin

Intervention Type: DRUG

Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated

Comparative group

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

Group Type: ACTIVE_COMPARATOR

Doxycyclin

Intervention Type: DRUG

Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated

Pentoxifylline

Intervention Type: DRUG

Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity

Nitazoxanide 500Mg Oral Tablet

Intervention Type: DRUG

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

Interventions

Doxycyclin

Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated

Intervention Type: DRUG

Pentoxifylline

Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt

UNKNOWN

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Teaching assisstant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3568

Identifier Type: -

Identifier Source: org_study_id