Nikhil Gupte, PhD

CRS:

BJMC

Role:

Regulatory and Data ManagementResearch Staff

Position:

CRS Data Manager and Deputy Director

Nikhil Gupte, PhD, is a Research Associate faculty member at the Johns Hopkins School of Medicine and Deputy Director of the Byramjee Jeejeebhoy Government Medical College (BJGMC)-JHU Clinical Trials Unit (CTU), a collaborative research partnership associated with the world’s largest HIV therapeutic trials networks, the AIDS Clinial Trials Group [ACTG] and the International Maternal Pediatric and Adolescent AIDS Clinical Trial Network (IMPAACT).

Dr. Gupte has more than 10 years of experience in public health research in developing countries and is a recognized leader in biostatistics education in India. Based in Pune, India, Dr. Gupte is the lead statistician for the BJGMC-JHU CTU, which conducts Phase I, II and III clinical trials of therapeutic drug interventions for HIV and co-morbid infections, such as tuberculosis and hepatitis, in adults (including pregnant women) and children. An experienced educator, Dr. Gupte has developed and taught biostatistics courses in India, including a number of University courses and NIH-supported training courses, and he currently leads the Biostatistics training for the BJGMC-JHU Fogarty HIV-TB Training Program.

A recipient of the Hopkins Fogarty fellowship, Dr. Gupte received a Doctor of Philosophy in Biostatistics from the Johns Hopkins Bloomberg School of Public Health.

  • Member, Site Operations Subcommittee
  • NWCS 319, parent study A5175
  • NWCS 408, parent study A5274
  • NWCS 414, parent study A5274

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Categories

Leadership Committees
CRS
Roles

Clinical Trials

P1108: A Phase I/II, Open-Label, Single Arm Study to...

This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in...

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P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

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A5354/EARLIER: Effect of Antiretroviral Treatment Initiated...

This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs...

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P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate...

The study is designed to characterize the pharmacokinetics of DLM using a model-based approach, and to evaluate safety and...

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A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

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