Current and Future Challenges in Trial Design for Pre-Exposure Prophylaxis in HIV Prevention
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Deborah Donnell
Abstract
Success in establishing efficacy of antiretroviral drugs to prevent acquisition of HIV infection has fundamentally changed the trial design considerations for future experimental drugs. Current trials of potential new antiretroviral agents for pre-exposure prophylaxis are using active control designs – where all trial participants receive an active antiretroviral drug. Current trials of other experimental approaches, such as vaccines and monoclonal antibodies, permit use of the proven prevention agent FTC/TDF for all trial participants. In the future, if even more effective prevention methods are approved, active control designs would anticipate very few infection events and not provide statistically robust evidence. A potential alternative is to conduct placebo randomized trials limited to participants for whom current prevention tools are not acceptable.
Funding statement: This work was supported by the National Institute of Allergy and Infectious Diseases, Grant Number: UM1AI068617.
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© 2019 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Articles
- Designing the Next Generation of HIV Prevention Efficacy Trials: Synopsis of a 2018 Symposium
- Current and Future Challenges in Trial Design for Pre-Exposure Prophylaxis in HIV Prevention
- Ongoing Vaccine and Monoclonal Antibody HIV Prevention Efficacy Trials and Considerations for Sequel Efficacy Trial Designs
- The Modern Randomized Clinical Trial: Is it Time to Sharpen a Blunt Instrument?
- The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents
- Regulatory Perspectives for Streamlining HIV Prevention Trials
- Advancing Novel PrEP Products – Alternatives to Non-Inferiority
- Designing & Conducting Trials to Reliably Evaluate HIV Prevention Interventions
- Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design
- Tomorrow’s HIV Prevention Trials of Vaccines and Antibodies
Artikel in diesem Heft
- Articles
- Designing the Next Generation of HIV Prevention Efficacy Trials: Synopsis of a 2018 Symposium
- Current and Future Challenges in Trial Design for Pre-Exposure Prophylaxis in HIV Prevention
- Ongoing Vaccine and Monoclonal Antibody HIV Prevention Efficacy Trials and Considerations for Sequel Efficacy Trial Designs
- The Modern Randomized Clinical Trial: Is it Time to Sharpen a Blunt Instrument?
- The Connection between the Averted Infections Ratio and the Rate Ratio in Active-control Trials of Pre-exposure Prophylaxis Agents
- Regulatory Perspectives for Streamlining HIV Prevention Trials
- Advancing Novel PrEP Products – Alternatives to Non-Inferiority
- Designing & Conducting Trials to Reliably Evaluate HIV Prevention Interventions
- Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design
- Tomorrow’s HIV Prevention Trials of Vaccines and Antibodies
