Impact of antimicrobials on penile HIV susceptibility and immunology in uncircumcised men: A randomized phase 1/2 clinical trial.

🤖 Plain-English Summary

Within the penile microbiome, bacteria associated with seroconversion, immunology, and cells (BASIC species) enhance HIV susceptibility in heterosexual uncircumcised men by inducing foreskin inflammation and HIV target cell recruitment. Immune alterations correlate strongly with changes in the abundance of BASIC species.

🔑 Key Findings

• This phase 1/2 clinical trial randomizes HIV-uninfected Ugandan men (n = 125) to either oral tinidazole, topical metronidazole, topical clindamycin, or topical hydrogen peroxide to define impact on ex vivo foreskin HIV susceptibility, penile immunology, and BASIC species density.
• Antimicrobials are well tolerated, and 116 (93%) participants complete the protocol.
• Topical metronidazole and oral tinidazole reduce the inner foreskin tissue density of HIV-susceptible CD4 T cells (predefined primary endpoint).

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