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Development of Human Microbiota01:30

Development of Human Microbiota

The human microbiota begins developing at birth and undergoes continual change as we age. Infancy marks a critical period of microbial sensitivity, offering a “window of opportunity” during which beneficial microbes help mature the immune system. By age three, children typically develop a more stable and diverse microbial community. Newborns acquire microbes from their immediate environment; vaginal delivery favors maternal vaginal microbes, while cesarean births favor microbes from the skin...
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Autonomous and Rechargeable Microneurostimulator Endoscopically Implantable into the Submucosa
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Published on: September 27, 2018

Rectal microbicide development.

Ian McGowan1, Charlene Dezzutti

  • 1University of Pittsburgh School of Medicine, 204 Craft Ave Room B621, Pittsburgh, PA, 15213, USA, imcgowan@pitt.edu.

Current Topics in Microbiology and Immunology
|April 25, 2013
PubMed
Summary
This summary is machine-generated.

Recent advancements show rectal microbicides, like tenofovir gel, are promising for HIV prevention. Phase 1 studies assessed safety and pharmacokinetics, paving the way for larger effectiveness trials.

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Area of Science:

  • Infectious Diseases
  • Pharmacology
  • HIV Prevention Research

Background:

  • Significant progress has been made in HIV prevention strategies including oral pre-exposure prophylaxis, vaginal microbicides, and treatment as prevention.
  • Antiretroviral microbicides have shown promise in preclinical non-human primate models for protection against rectal HIV transmission (SIV/SHIV).

Purpose of the Study:

  • To characterize the safety, acceptability, pharmacokinetics (PK), and pharmacodynamics (PD) of rectal microbicide candidates.
  • To evaluate newer rectal-specific formulations of microbicides, as vaginal formulations were not well tolerated rectally.

Main Methods:

  • Phase 1 clinical studies were conducted to assess rectal microbicide candidates.
  • Safety, acceptability, compartmental PK, and PD data were collected for UC781 and tenofovir gels.

Main Results:

  • Tenofovir gel, a vaginal formulation, showed poor rectal tolerability; newer rectal-specific formulations have been developed and evaluated.
  • Phase 1 PK/PD data provide crucial information to guide the development of effective rectal microbicides.

Conclusions:

  • Rectal microbicide development is advancing, with tenofovir gel progressing towards Phase 2 evaluation.
  • PK/PD data from early-stage studies are essential for efficient advancement of promising rectal microbicide candidates into late-stage efficacy trials.