Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03412071
Status:
UNKNOWN
Last Update Posted:
2018-01-26
First Post:
2018-01-19
Brief Title:
Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
RATIONALE The foreskin is the site of most HIV acquisition in uncircumcised heterosexual men and male circumcision MC reduces HIV risk by almost 60 However cultural and practical barriers have led to suboptimal uptake Foreskin inflammation defined by elevated levels of pro-inflammatory cytokines in the prepuce is a key determinant of HIV acquisition risk in uncircumcised men and anaerobic bacteria within the foreskin microbiome may be an important cause of this inflammation
OBJECTIVES A pilot in vivo - in vitro clinical study of four potential interventions to reduce HIV susceptibility in the foreskin by altering the microbiome The study is a collaboration between the University of Toronto IAVI-UVRI and the Entebbe General Hospital We will recruit 125 men presenting for elective MC along with regular female sexual partners if applicable Participants will be randomized n25 per group to immediate MC or to one of four intervention arms twice-daily application of topical metronidazole 075 twice-daily application of topical clindamycin 2 twice daily application of hydrogen peroxide 1 or oral tinidazole 2g once a day for two days Swabs for immune and microbiome studies will be collected before and after product After 4 weeks the MC procedure will be performed foreskin CD4 T cell susceptibility to HIV will be quantified using a flow cytometry-based pseudovirus assay and tissue immunohistochemistry performed The primary and secondary endpoints are outlined below A secondary study will assess the impact of penile topical antibiotic application on immunology and the microbiome in the genital tract of female sexual partners
OUTCOMES This in vivo - in vitro clinical trial will define the causal role of the penile microbiome in HIV susceptibility and will assess potential strategies to take forward into HIV efficacy trials in uncircumcised heterosexual men
OBJECTIVES A pilot in vivo - in vitro clinical study of four potential interventions to reduce HIV susceptibility in the foreskin by altering the microbiome The study is a collaboration between the University of Toronto IAVI-UVRI and the Entebbe General Hospital We will recruit 125 men presenting for elective MC along with regular female sexual partners if applicable Participants will be randomized n25 per group to immediate MC or to one of four intervention arms twice-daily application of topical metronidazole 075 twice-daily application of topical clindamycin 2 twice daily application of hydrogen peroxide 1 or oral tinidazole 2g once a day for two days Swabs for immune and microbiome studies will be collected before and after product After 4 weeks the MC procedure will be performed foreskin CD4 T cell susceptibility to HIV will be quantified using a flow cytometry-based pseudovirus assay and tissue immunohistochemistry performed The primary and secondary endpoints are outlined below A secondary study will assess the impact of penile topical antibiotic application on immunology and the microbiome in the genital tract of female sexual partners
OUTCOMES This in vivo - in vitro clinical trial will define the causal role of the penile microbiome in HIV susceptibility and will assess potential strategies to take forward into HIV efficacy trials in uncircumcised heterosexual men
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None