January 2012 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

• Preclinical Innovation Program
• Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention
• Delivering Therapeutics to Active HIV Reservoirs
• Innovation for HIV Vaccine Discovery
• Integrated Preclinical/Clinical AIDS Vaccine Discovery

Preclinical Innovation Program

For the published request for applications, see the March 7, 2013, Guide announcement.

Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention

Request for Applications

Contact: Jim Turpin

Objective:

• Stimulate a strong, diverse base in preclinical discovery and development of new topical microbicides and biomedical prevention strategies.
• Develop combination and sustained release strategies for vaginal, penile, rectal, oral, and/or injectable use.
• Support translation from preclinical to pre-phase I clinical studies.

Address the following scientific priorities:

1. Need for sustained delivery of prevention strategies to address need for coitally disassociated prevention options.
2. Advancement of single and combination PrEP and microbicide candidates to clinical testing as part of an overall program to ensure sustainability of the prevention pipeline.
3. Rectal microbicides.
4. Develop quantitative methods to measure and enhance adherence.
5. Develop PK/PD models to guide prevention strategy development.
6. Develop Multipurpose Prevention Technologies.

Description: This initiative will support the broad range of research necessary to advance well-characterized, nonvaccine biomedical prevention (microbicides and PrEP) leads and strategies into clinical studies. Specific types of supportable research include:

1. Developing new single or combination microbicides and PrEP agents for vaginal, rectal, penile, oral, and implantable use.
2. Identifying and validating new targets and strategies.
3. Integrating with other prevention strategies.
4. Developing new and optimizing existing delivery methods, including male and female genital tract, GI tract, oral, and implantable strategies with the aim of creating long lasting, minimal dosing, coital disassociated dosing strategies.
5. Exploring the relationship between behavioral and social factors affecting adherence and acceptability and the biophysical properties of formulated microbicides.
6. Developing quantitative methods to objectively measure and enhance product adherence.
7. Developing PK and PD models to assist in dosing of prevention strategies and optimize efficacy and safety and dose selection.
8. Pre-phase I trials to study the pharmacology, distribution, and effect of microbicides on the female reproductive tract mucosa and GI tract mucosa.

The overarching objective of the IPCP-MBP is to assure a sustainable pipeline of nonvaccine, biomedical prevention candidates and strategies for clinical testing by the DAIDS networks and other clinical partners.

Delivering Therapeutics to Active HIV Reservoirs

For the published request for applications, see the January 15, 2013, Guide announcement, Delivering Therapeutics to Residual Active HIV Reservoirs.

Innovation for HIV Vaccine Discovery

For the published request for applications, see the January 15, 2013, Guide announcement.

Integrated Preclinical/Clinical AIDS Vaccine Discovery

For the published program announcement, see the December 14, 2012, Guide announcement, Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD).