Investigator Studies Program (MISP): HIV

Effective March 2021, the HIV Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI). This is a competitive process that will be conducted by the HIV MISP in 2021. 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 program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

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 (PLWH) including but not limited to patients at risk for co-morbidities and toxicities, such as: CNS disease, cardiovascular disease, hyperlipidemia, hepatic dysfunction, metabolic and renal abnormalities. Establish the tolerability and convenience of antiretroviral therapy, in larger numbers of patients in these groups, which have been underrepresented in clinical trials and increasingly comprise the majority of PLWH.
• Special populations: Different races and ethnicities, women and aging PLWH. Establish the tolerability and convenience of antiretroviral therapy, in larger numbers of patients in these groups, which have been underrepresented in clinical trials and increasingly comprise the majority of PLWH.
  • 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.
• 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. Efficacy of doravirine-based regimens in PLWH harboring ARV-resistant isolates.
• Drug- drug Interactions: Studies that focus on potential interactions between doravirine-based 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/preferences regarding types and modes of prevention (oral, systemic; daily, long-acting); strategies to facilitate uptake and long-term adherence; alternative models that “de-medicalize” access to prevention modalities
• Pathogenesis: Inflammation and biomarkers, eradication and viral reservoirs.

Islatravir only

• MOA Studies – to enable a deeper understanding of MOA and differentiate it as a novel NRTTI (biochemistry/structural biology/cell biology/virology)
• Resistance studies – elucidate pathways of resistance, fitness cost of mutations and barrier to resistance in HIV-1 clinical isolates across subtypes to impact algorithms geared at interpreting potency shifts (virology/cell biology)
• Antiviral activity – studies to evaluate impact on latent reservoirs, archive DNA to differentiate it on potency from other antiretrovirals (virology/ex-vivo/ in vivo models)
• Markers of Inflammation/immune dysfunction (cell biology/in vivo models) – studies to relate biomarkers with antiviral activity and demonstrate benefit for patients

Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the HIV MISP Committee.

Critical Activities and Timelines:

Submission Requirements	2021 Deadlines	2021 Review Committee Dates
Protocol	N/A	March 30, 2021
Detailed Preclinical or Clinical Budget	March 23, 2021	April 28, 2021
Principal Investigator CV	N/A	May 25, 2021
	N/A	June 22, 2021
	N/A	July 13, 2021
	July 6, 2021	August 10, 2021
	N/A	September 14, 2021
	N/A	October 5, 2021
	October 4, 2021	November 9, 2021

MISP Information
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.