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September 2013 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests 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

Innovation for HIV Vaccine Discovery

For the published request for applications, see the February 18, 2014, Guide announcement, Innovation for HIV Vaccine Discovery (R01).

Prevention Innovation Program

For the published request for applications, see the February 20, 2014, Guide announcement, Prevention Innovation Program (PIP) (R01).

Mucosal Environment and HIV Prevention II

For the published request for applications, see the July 22, 2014, Guide announcement, Mucosal Environment and HIV Prevention (MEHP II) (R01).

Synthesis of Therapeutic Agents for Treatment of Infectious Diseases

For the published request for proposals, see the March 6, 2014, solicitation, Synthesis of Therapeutic Agents for Treatment of Infectious Diseases.

Host-Directed TB Therapy: New Approaches

Request for Applications

Contact: Sudha Srinivasan

Objective: Establish treatment and prevention strategies for HIV-associated infections of highest morbidity and mortality, especially tuberculosis (TB).

Description: Recent work on host-pathogen interaction/host immunity suggests that host-directed therapy (immunomodulators) could lead to shorter treatment and improved outcomes by modifying TB-induced immune effects and/or by decreasing local tissue pathology and bacterial sanctuaries, particularly in the setting of HIV infection. This initiative will support limited preclinical work needed to advance host-directed therapeutic strategies for TB into proof-of-concept clinical trials. Agents that may also have therapeutic activity against HIV either directly or by enhancing immunologic reactions are of particular interest. Preclinical studies in animal models that are known to have the most similarity in immunologic mechanisms to humans (e.g., nonhuman primates) are encouraged. Types of agents that may be studied include small-molecule agents that modulate destructive immune-mediated inflammatory responses (cytokine inhibitors, eicosanoid synthesis pathway inhibitors, etc.), agents to allow host immune cells to prevent or inhibit cell entry and survival of TB through reversal of functional defects (e.g., autophagy enhancement), stimulate the immune clearance of TB, or directly protect tissues from inflammatory damage. A plan for a proof-of-concept clinical trial is required.

To be responsive to this RFA, applications must:

  • Propose study of agents that target host mechanisms, have preclinical evidence of therapeutic benefit in an appropriate TB treatment animal model, and either have FDA approval or are in phase II or III clinical trials.
  • Propose developing or evaluating interventions that are primarily intended for persons who are also infected with HIV and include a rationale for specific benefit in the context of HIV/TB coinfection.
  • Propose developing or evaluating interventions that will be tested further in studies within the TB research agenda of the DAIDS-funded clinical research networks. A letter must accompany these applications and must describe: 1) how the work will advance such studies, 2) document discussions held with network leadership that led to the submission, and 3) define the proposed network collaboration.

U.S.-South Africa Program for Collaborative Biomedical Research on HIV, TB, and HIV-Related Malignancies

For the published request for applications, see the December 13, 2013, Guide announcements, U.S.-South Africa Program for Collaborative Biomedical Research (R21) and U.S.-South Africa Program for Collaborative Biomedical Research (R01) and the January 24, 2014, Guide announcement, U.S.-South Africa Program for Collaborative Biomedical Research (U01).

Biomedical Methods to Quantify Adherence to Prevention Clinical Trial Study Products and Strategies

Request for Proposals

Contact: Eileen Webster-Cissel

Objective: The goal of this SBIR contract solicitation is to support small businesses interested in developing novel and innovative technologies to quantify adherence to the clinical trial strategy used in HIV prevention clinical trials. Applicants may propose to develop innovative biomedical, electronic, and/or analytical technologies that are independent of subject reporting biases to determine clinical trial product/strategy adherence. Proposed approaches should be accurate and reproducible and, ideally, able to quantify a subject’s adherence when used either remotely by trial participants, during clinical study visits, or within one week of a study visit. Technologies must quantify adherence to the placebo(s) and the study drug(s). Proposals to further develop or optimize MEMS caps, Wisebags™, and applicator staining methods are not responsive to this solicitation. Behavioral/social determinations of product use/adherence as comparators to demonstrate efficiency, accuracy, and/or fidelity of the methods under development are appropriate for incorporation into proposals. The developed methods, strategies, and/or instrumentation should be cost effective and have a defined regulatory pathway, and should not significantly increase participant or site personnel burden.

Description: The critical role of adherence in providing reliable estimates of product and/or strategy efficacy in preventing HIV transmission was recently highlighted by the outcome of the VOICE trial. This five-arm trial (oral Tenofovir, oral Truvada, oral placebo, 1 percent Tenofovir vaginal gel, and gel placebo) required the daily use of products by women at risk for HIV infection. As reported at CROI 2013, the VOICE study failed to confirm the efficacy of 1 percent Tenofovir gel and oral Truvada observed in previous clinical trials. Multiple measures of adherence (self-reports, pill and applicator counts) were incorporated into the VOICE trial and they suggested high overall adherence (>90 percent). However, less than 30 percent of the women had detectable levels of drug in their plasma at study visits. The results suggest that current approaches to measuring adherence are not capturing product use accurately. Although many biological, behavioral, and social factors may influence adherence, there is a critical need for accurate, real-time methods to quantify product adherence independent of trial participant bias.

Oral Formulation for Antibiotics of Public Health Importance

Request for Proposals

Contact: Eileen Webster-Cissel

Objective: The goal of this solicitation is to develop an effective oral dosing formulation or modification of licensed antibiotics that are currently available only as intravenously or parenterally-administered formulations, specifically, capreomycin, meropenem, imepenem, or vancomycin. Considerations for formulation may also include mitigation of adverse drug reactions. An example is an oral formulation of capreomycin that maintains efficacy while possibly decreasing adverse events (nephrotoxicity and ototoxicity) for use as part of a drug regimen for treating multidrug-resistant tuberculosis (MDR-TB). A second example is an oral formulation of vancomycin that allows for systemic absorption in order to treat methicillin-resistant Staphylococcus aureus (MRSA).

Description: Multidrug-resistant pathogens such as MDR-TB, gonorrhea, and staphylococcus are increasingly challenging to treat. Currently existing drugs for treating MDR-TB are only moderately potent, show restrictions with absorption or oral bioavailability, and have toxicity profiles that make patient management difficult. There are two important classes of injectable drugs for TB: aminoglycosides (amikacin and kanamycin) and polypeptides (capreomycin). Capreomycin is recommended for use in cases of known or suspected resistance to the aminoglycosides and seems to have activity against nonreplicating persister bacilli, unlike aminoglycosides. However, it is painful to receive by injection and is associated with severe systemic side effects, including nephrotoxicity and ototoxicity. Similarly, treatment of drug-resistant Neisseria gonorrhoeae is an escalating public health concern due to the unavailability of oral dosage forms of antibiotics that are efficacious for this infection. Effective treatment of MRSA is also challenging to manage because it requires long-term intravenous administration of vancomycin. Oral formulations of licensed antibiotics to treat these and other bacterial pathogens of public health importance are wanted, particularly to address the growing incidence of drug resistant infections.

Simple, Inexpensive Assay for Five Common HIV Resistance Mutations

Request for Proposals

Contact: Eileen Webster-Cissel

Objective: The goal of this solicitation is to develop an inexpensive, easy-to-use assay that will detect the presence or absence of five common HIV drug resistance mutations in blood samples from patients failing HAART regimens in resource-limited countries.

Description: Antiretroviral therapy in resource-limited countries generally includes two nucleoside reverse transcriptase inhibitor (NRTI) and one non-nucleoside reverse transcriptase inhibitor (NNRTI). While these HAART regimens are very potent and reduce viral load to undetectable levels in most patients, drug resistance occurs in some patients after long-term therapy. The WHO has published a report of HIV resistance including data from 40 surveys conducted in 12 countries from 2006 to 2012. These surveys indicate that there are resistance mutations that predominate among patients failing therapy after 12 months. These mutations include the NNRTI resistance mutations K103N and Y181C, the tenofovir and d4T resistance mutation K65R, the 3TC/FTC resistance mutation M184V, and the most common thymidine analog resistance mutation D67N. The ability to quickly and easily detect these five mutations after virological failure could help optimize second line therapy regimens.

Last Updated July 22, 2014

Last Reviewed July 22, 2014