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Clinical research with topical microbicides as a potential HIV prevention method
1HIV/STD Research and Intervention Unit, Institute of Tropical Medicine, Antwerp, Belgium.
The AIDS Reader
|October 6, 2000
Summary
This research reviews microbicide development, focusing on nonoxynol-9. Despite challenges, phase III trials for microbicides are feasible and urgently needed.
Area of Science:
- Microbiology and infectious disease research.
- Clinical trial design and ethics.
Background:
- Overview of microbicide research phases.
- Nonoxynol-9 as the sole microbicide candidate advanced to Phase III trials.
- Previous research in microbicide development and efficacy.
Purpose of the Study:
- To detail the phases of microbicide research.
- To highlight methodological and ethical challenges in Phase III trials.
- To assess the feasibility of initiating Phase III microbicide studies.
Main Methods:
- Review of existing microbicide research phases.
- Analysis of challenges in Phase III trial conduct.
- Discussion of specific issues: study population, compliance, standardization, therapy, and informed consent.
Main Results:
- Nonoxynol-9 is the only microbicide ingredient tested in Phase III trials to date.
- Significant methodological and ethical challenges exist for Phase III microbicide trials.
- Key challenges include defining study populations, ensuring compliance, standardizing protocols, providing therapy for HIV-positive women, and obtaining informed consent.
Conclusions:
- Phase III trials for microbicides are methodologically and ethically challenging but feasible.
- Initiation of Phase III trials is recommended despite the identified obstacles.
- Further research and careful planning are needed to overcome these challenges in microbicide development.