Announcements

On Behalf of IDSA: Urge Lawmakers to Protect PEPFAR Funding

MAY-22-13 IDSA is asking for you to join them and lend your name to a letter in support of PEPFAR funding for the next fiscal year. Click here to read the letter and sign by Monday, June 3-Noon Eastern time.

Renewal of the National Viral Hepatitis Action Plan, 2014-2016

MAY-20-13 Dr. Ronald Valdiserri writes to recognize the second anniversary of Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care & Treatment of Viral Hepatitis and to share an important announcement from Dr. Howard Koh about plans to update and renew the existing plan through 2014-2016.

HIV Forum congrulates Nina Mani on her new position at FDA

MAY-17-13 Please join the Forum in congratulating Nina Mani on an exciting new career move. Nina is leaving the Forum, but she is not going far – starting June 3 she will join the FDA Center for Drug Evaluation Research, Division of Antiviral Products. That we will miss her is the understatement of the century. But the offer to join our colleagues at the FDA as a project manager presented a phenomenal opportunity – an excellent fit for her career path. We congratulate Jeff, Kim, Jules and Patrick on an excellent choice! We imagine that many of you will have the pleasure of interacting with her in her new capacity.

National Viral Hepatitis Action Plan to Be Renewed

MAY-16-13 Dr. Howard Koh, the Assistant Secretary for Health, announced on May 16 that the partner agencies are committed and dedicated to renewing the Action Plan for another three years and are currently working on their vision and priorities for 2014-2016.

HIV Forum Mourns the Passing of Executive Committee Member Dr. Jim Goodrich

MAY-10-13 We are saddened to report the death of James Goodrich, PhD, MD of ViiV Healthcare, a member of the Forum’s Executive Committee. Jim passed away unexpectedly last weekend and is survived by his wife, Carolyn and two teenage daughters. A memorial service for Jim will be held this summer on a date to be determined. Jim has been a considered and thoughtful participant on the Executive Committee. His desire to improve care for patients, direct approach and sense of humor will be missed. Please join us in keeping Jim’s family in our thoughts and prayers.

Upcoming Events

29-Jun-13

IAS 2013 Towards an HIV Cure Symposium

14-Jun-13

FDA Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research

04-Jun-13

International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies

23-May-13

Hepatitis B and C Testing and Awareness Day in House of Representatives

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Immune-based Therapies

Materials and Links

Immune-based Therapies and HIV Disease, December 2000

Immune-based_Therapies: A Review of Clinical Endpoints Used in Trials of Selected Immunologic Agents, December 2000

Immunological_Markers to Evaluate Immune-Based Therapies in HIV Disease Meeting Report, December 2000

Background:

While the use of highly active anti-viral therapy (HAART) has lowered the level of virus in the blood stream, immune reconstitution may offer additional benefits in maintaining viral suppression and enhancing immune function. Clinical trials in immune-based therapy (IBT) must to be designed to capture endpoints that will allow approval of these agents by regulatory agencies. Appropriate indices of immune function and competence need to be identified and validated.

Forum Activities

In December 2000, the Forum held a meeting for invited scientists, researchers, and pharmaceutical, government, and community representatives, on Immune-Based Therapies and HIV Disease. The focus of the meeting was on immune-based therapies (IBTs) and indices of immune competency for HIV research. Participants discussed indices of immune function, biomarkers that can be used to evaluate the efficacy of immunologic agents in HIV disease and the validation of these indices along with questions of how to overcome barriers in developing immune-based agents and designing and implementing clinical trials. The participants identified the gaps in the research and made recommendations to advance our understanding of immune pathogenesis in HIV disease, identify and validate appropriate markers, and determine how these markers can be used in research of immune-based therapies. They also outlined some general considerations for the design clinical trials of IBTs based on surrogate markers of bioactivity.

As background information for participants attending the Forum's workshop, a report Immune-based therapy for HIV treatment and prevention: A review of clinical endpoints for trials of immunologic agents was prepared to address issues related to the discussion questions. The report reviewed study designs and endpoints used in phase II and phase III trials for 13 immunologic agents.

One outcome of the December 2000 meeting was the suggestion to hold small focused meetings to concentrate on well-defined topics. On February 6, 2001, the Forum held a meeting in Chicago, IL to discuss ways to promote the selection, refinement, and evaluation of immunologic markers used to assess immune-based therapies in people with HIV infection.

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