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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Drug: Doxycyclin; Drug: Pentoxifylline; Drug: Nitazoxanide 500Mg Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; This group will take doxycycline 100 mg twice daily	Drug: Doxycyclin; Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated
Active Comparator: Comparative group; This group will take doxycycline 100 mg twice daily, pentoxifylline 400 mg twice daily, and nitazoxanide 500 mg twice daily.	Drug: Doxycyclin; Doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated; Drug: Pentoxifylline; Pentoxifylline is a vasoactive agent that improves the flow of blood by reducing its viscosity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment of chylamdia in sexually active men	treatment of chylamdia in sexually active men and decreasing resistance to antibiotics	1 month

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Mostafa Mahmoud Bahaa Clinical Pharmacy Department, Horus University, New Damietta, Egypt; Marwa Ahmed El-Samongy Dermatology and Venereology Department, Tanta University.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2028

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Anti-Infective Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Antimalarials; Radiation-Protective Agents; Doxycycline; Nitazoxanide; Pentoxifylline
• Other Study ID Numbers: 3568

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No