The Forum HIV Cure Research Project convened a series of meetings to address the clinical trial and regulatory issues surrounding HIV cure research. Focusing on the ethical, regulatory and clinical factors of HIV cure research, the project utilized the traditional Forum approach of engaging key stakeholders, including those from the FDA, NIH, academia, advocates, and industry.
The Forum HIV Cure Project: Year 2
As we enter year 2 of the project, the activities of the three WG have evolved to focus on:
- Working Group#1: Preclinical animal models
- Spreadsheet on the performance of various curative interventions in eradicating latent HIV (or SIV) in NHPs and humanized mice models while highlighting the strengths and weaknesses of different approaches in the respective animal models.
- Please email the Forum with any edits or comments you may have on the spreadsheet at This e-mail address is being protected from spambots. You need JavaScript enabled to view it
- Working Group#2: Network for focused/targeted discussion on specific strategies
- Working Group#3: Patient recruitment and informed consent- Interdisciplinary research interaction
Veronica Miller provided an update on the Forum HIV Cure Project at the Strategies for an HIV Cure Meeting on Oct 15-17, 2014 at the National Institutes of Health. Click here to view her slides.
The Forum HIV Cure Project: Year 1
The Forum HIV Cure Project: Regulatory Pathway for HIV Cure Research meeting was held at the Kaiser Family Foundation, Barbara Jordan Conference Center on June 17th.
Meeting Survey Results (uploaded 8-15-14)
Session 2: Arriving at a Common Language: Clarity, Definitions, Expectations, and Goals
Session 3: Ethics and Fairness in Trial Recruitment, Participant Education, and Informed Consent
Session 4: Cure Research in Maternal/Pediatric Setting
Session 5: Managing Risk Benefit in Clinical Trials
Session 6: REDUC Trial Case Study
Session 7: RV397 Protocol Case Study
Session 8: Hypothetical Case Study - vorinostat and CAR-modified CD8+ T Cells
Background Documents:
Informed Consent in HIV Cure-Oriented Studies: Guidance and Recommendations for Future Research
Proposed Recommendations for HIV Cure Survey Research
HIV Cure-related Clinical Trials Excel
Moderator and Panelist Biosketches
In-person Meeting Participant List
The project has two main components:
- Targeted Expert Working Groups: An ongoing multi-stakeholder expert working group process to discuss (clarify and derive consensus where possible) specific scientific and regulatory hurdles encountered in cure research
- Opportunities for Open Public Input: An ongoing, open process to seek input from the broader HIV community on specific regulatory issues in cure research - such as acceptable risk, ethics, informed consent and appropriate populations - through surveys and other online tools, partnered with an all-day workshop on June 17th that will be open to the public and simultaneously webcasted
Status:
The project has convened three main working groups to address specific HIV cure-related scientific and regulatory issues - which will be presented during the June 17th meeting:
- Working Group #1: Trial endpoints, biomarkers and definitions, chaired by John Mellors (UPitt) and Mike Miller (Merck)
- Working Group #2: Clinical science and management of cure trials, chaired by Jintanat Ananworanich (USMHRP) and Joseph Eron (UNC)
- Working Group #3: Patient education, recruitment and informed consent, chaired by David Evans (Project Inform) and Tim Henrich (HMS/BWH)
The overall Steering Committee for this project includes:
| Co-Chairs: | |
| Daniel Kuritzkes, MD | Harvard Medical School; Brigham & Women’s Hospital |
| Veronica Miller, PhD | Forum for Collaborative HIV Research |
| Community: | |
| David Evans | Project Inform |
| Mark Harrington | Treatment Action Group |
| Federal Government: |
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| Jintanat Ananworanich, MD, PhD | US Military HIV Research Program |
| Jeffrey Murray, MD, MPH | Center for Drug Evaluation & Research/FDA |
| Sarah Read, MD, MHS | Division of AIDS/NIAID |
| Paul A. Sato, MD, MPH | Office of AIDS Research/NIH |
| Celia Witten, PhD, MD | Center for Biologics Evaluation & Research/FDA |
| Carol Weiss, MD, PhD | Center for Biologics Evaluation & Research/FDA |
| Foundations: | |
| Stephen Becker, MD | Bill & Melinda Gates Foundation |
| Rowena Johnston, PhD | American Foundation for AIDS Research |
| Academia: | |
| John Mellors, MD University of Pittsburgh | |
| Industry: | |
| Romas Geleziunas, PhD | Gilead Sciences, Inc |
| George Hanna, MD | Bristol-Myers Squibb |
| Daria Hazuda, PhD | Merck Research Laboratories |
| Winson Tang, MD, FACP | Sangamo Biosciences, Inc |
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