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Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men

NCT03412071 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-01-26

No results posted yet for this study

Summary

This pilot study will assess the impact of four antimicrobial products (3 topical, one systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells. Participants will include HIV-uninfected Ugandan men presenting for elective male circumcision to reduce their HIV risk.

Conditions

  • Foreskin HIV Susceptibility

Interventions

DRUG

Oral Tinidazole

Please see description under arms

DRUG

Topical metronidazole

Please see description under arms

DRUG

Topical Clindamycin

Please see description under arms

DRUG

Topical Hydrogen Peroxide

Please see description under arms

Sponsors & Collaborators

  • UVRI-IAVI HIV Vaccine Program

    collaborator UNKNOWN

  • Entebbe General Hospital

    collaborator UNKNOWN

  • University of Toronto

    lead OTHER

Principal Investigators

  • Rupert Kaul, MD/PhD · University of Toronto

  • Ronald M Galiwango, MBChB/MSc · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2019-12-07
Completion
2019-12-07

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412071 on ClinicalTrials.gov