One in eight people living with HIV resides in India. Yet for the majority of India’s estimated 5.7 million HIV-infected citizens, the cost of antiretroviral therapy remains prohibitively high. As of 2005, there was not yet a coordinated research plan in this area, and it was both important and urgent to develop a comprehensive research agenda to investigate and evaluate the use, efficacy, safety, and cost-effectiveness of TIM for HIV/AIDS.
In response to this need, Samueli Institute, the Center for Clinical Global Health Education (CCGHE) at Johns Hopkins University School of Medicine, and the Indian Council of Medical Research (ICMR), jointly organized a Research Agenda Conference on TIM and HIV/AIDS in New Delhi, India in September 2006.
This international conference convened selected conventional HIV/AIDS clinicians, TIM practitioners, research scientists and Indian government officials to develop a focused and feasible research agenda to identify and assess the impact TIM has on HIV care and treatment in India. Participants identified four priority areas for research on TIM for HIV/AIDS:
- Training, infrastructure and research methodology: Participants identified a need for more training in grant writing, research publication procedures and bioethics. They suggested issuing an RFA to prioritize research proposals, developing a Center of Excellence for research on TIM, and creating an international research alliance and web site to facilitate electronic communication.
- Effectiveness research: Participants made recommendations for effectiveness research in five areas: prevention of HIV infection, delaying the onset of AIDS, treating AIDS and HIV-related illnesses, cure, and research methodology.
- Observational research/ epidemiology: Participants identified several key areas of research need related to surveillance of HIV/AIDS and TIM usage, integration of care and research methodology.
- Product safety: Recommendations included improving characterization and standardization of TIM-based pharmaceutical products, increasing testing of preclinical safety and drug interactions, and improving communication and research methodology.
Following the recommendations made at this conference, Samueli Institute co-funded JHU to conduct a
pilot study on the use of TIM for HIV/AIDS and associated illnesses, which is being conducted by an experienced JHU Clinical Trials Unit in Pune, India.