A combined approach towards an HIV cure requires the expertise from a consortium of world-class research groups with varied expertise. The following research cores are lending their skills and knowledge to the I4C program.
Core 1: Clinical
- Develop clinical protocols for Focus 1
- Coordinate and support scientific and regulatory submissions for pilot trials
- Assess clinical trial site readiness to conduct pilot clinical trials in accordance Good Clinical Practice (GCP) and all applicable DAIDS policies
- Develop and coordinate data collection and safety monitoring systems in conjunction with the Biostatistics and Bioinformatics SRS (SRS5)
- Stored biologic samples/clinical data from clinical sites
- Acquisition of fresh clinical samples (blood, leukopaks, colorectal tissue, lymph nodes) from HIV-infected and uninfected individuals
- Core Leaders: Jintinat Ananworanich, M.D., Ph.D.; Sharon Riddler
Core 2: Nonhuman Primate
- Provide the expertise and access to rhesus monkeys for the pre-clinical studies
- Core Leader: Dan H. Barouch, M.D., Ph.D.
Core 3: Virology
- Provide cutting edge virologic assays to characterize and quantitate the replication-competent viral reservoir and viral sequencing to support both the pre-clinical and the clinical studies
- Core Leaders: Robert Siliciano, M.D., Ph.D.; John Mellors
Core 4: Immunology
- Provide cutting-edge immunologic assays, involving neutralizing and non-neutralizing antibody assays including systems serology and cellular immune assays including epitope mapping studies to support both the pre-clinical and clinical studies
- Core Leaders: Galit Alter, Ph.D.; Dennis Burton, Ph.D.; Dan H. Barouch, M.D., Ph.D.; Col. Nelson Michael, M.D., Ph.D.
Core 5: Biostatistics and Bioinformatics
- Provide statistical and data management leadership and expertise
- Harmonize statistical and data management activities across trials in different phases
- Maximize the efficiency with which studies can be developed and implemented and ensure complete and accurate data and rigorous analysis of study data
- Core Leaders: Lu (Summer) Zheng, Ph.D.; Bette Korber, Ph.D.