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

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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05897034
Enrollment
100
Registered
2023-06-09
Start date
2023-06-20
Completion date
2028-06-20
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexually Transmitted Diseases

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.

Interventions

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

DRUGPentoxifylline

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

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

Sponsors

Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt
CollaboratorUNKNOWN
Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

double-blind

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
treatment of chylamdia in sexually active men1 monthtreatment of chylamdia in sexually active men and decreasing resistance to antibiotics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026