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

P2026: Pharmacokinetic Properties of Antiretroviral and...

IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women,...

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A5290, A Randomized, Phase 2b Study of a Double-Dose...

Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively...

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A5324: A Randomized, Double-Blinded, Placebo-Controlled...

ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC)...

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A5207, Maintaining Options for Mothers Study (MOMS): A Phase...

A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to...

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ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

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