Investigator Studies Program (MISP): HIV
Effective December 2018, the HIV Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 26, 2019 for the first review cycle, July 2, 2019 for the 2nd review cycle and September 17, 2019 for the 3rd review cycle. This is a competitive process that will be conducted by the HIV MISP in 2019. Decisions will be made on the basis of scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below.
The following areas are of interest to Investigator Studies Program Committee:
- Optimizing ARV regimens: Management of HIV to facilitate treatment of people living with HIV (PLWHIV) including but not limited to patients at risk for co-morbidities and toxicities, such as: CNS disease, cardiovascular disease, hyperlipidemia, hepatic dysfunction, renal abnormalities. Establish the efficacy and safety in larger numbers of patients in these groups, which have been underrepresented in clinical trials and increasingly comprise the majority of treated patients.
- Special populations: Different races and ethnicities, aging patients, and women. Establish the efficacy and safety in larger numbers of patients in these groups, which have been underrepresented in clinical trials and increasingly comprise the majority of PLWHIV.
- Investigate the impact of HIV and aging on the risk of co-morbidities and toxicities related to polypharmacy.
- Investigate the impact of HIV and antiretroviral therapy (ART) on the following gender/sex-based issues: reproductive health, contraception, pregnancy, neonatal outcome and menopause.
- Co-infection: Tolerability and ease of use of raltegravir and/or doravirine regimens in patients who require treatment for co-infection with drugs that often cannot be used with many antiretroviral medications such as HIV patients co-infected with HCV, TB or HBV.
- Drug- drug Interactions: Studies that focus on potential interactions between raltegravir and doravirine regimens and drugs used to treat underlying conditions such as: cardiovascular disease, hypertension, diabetes, bone disease, neuro-affective disorders.
- HIV prevention: Populations at high risk of HIV infection; patient attitudes/choices regarding types and modes of prevention (oral, systemic; daily, long-acting); strategies to facilitate uptake and long-term adherence
- Pathogenesis: Inflammation and biomarkers, eradication and viral reservoirs.
- HIV Resistance: Characterization of transmitted resistance; patterns of emergence of resistance and prevalence, especially in Non B subtypes; emergence of resistance in patients failing prior regimens; and efficacy in patients with viral resistance.
Please complete a full protocol and detailed budget via Visiontracker
, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the HIV MISP Committee.
Critical Activities and Timelines:
||1st Review Cycle
||2nd Review Cycle
||3rd Review Cycle
|Full Protocol Submission with Detailed Budget
||March 26, 2019
||July 2, 2019
||September 17, 2019
|HIV MISP Review: Full Review
||April 23, 2019
||July 30, 2019
||October 30, 2019
|Final Comments to Investigator
||May 7, 2019
||August 13, 2019
||November 12, 2019
|Final Protocol Submission by Investigator
||May 21, 2019
||August 27, 2019
||November 26, 2019
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator
Studies Program should contact their local MSD office