Introduction

Welcome to the Clinical Research Unit of the Center for Infectious Disease! Our team’s mission is to connect our community with outstanding clinical trials and exciting research opportunities. A clinical trial is a study in people that tries to answer scientific questions and find better ways to prevent, diagnose, or treat disease.

Many of our patients at CID participate in trials sponsored by the National Institutes of Health, as well as projects from major pharmaceutical companies. Our clinicians are also investigators within these NIH-funded research groups.

We offer a broad range of ongoing trials that members of the community may be eligible to participate in. During their clinic visits in CID, our team, with the assistance of their healthcare provider approach eligible individuals to see if they are interested in learning more about our clinical research programs.

We welcome collaboration from other investigators. If you are interested in finding out more about the CRU please contact us.

Publications

Our Current Studies

The HIV and Aging Study

The purpose of this study is to compare the aging of the immune system in people living with HIV to the general population.

Among persons living with HIV, a persistent state of immune activation and inflammation accelerates the process of aging. This causes people living with HIV to have immune system defects common in older populations. These effects persist despite suppression of HIV with antiretroviral medications.

We believe that advancing age and HIV synergistically promote residual HIV gene expression that acts as a persistent and potential stimuli of immune activation. In order to investigate this relationship, are collecting blood samples from young (under 35) and older (over 50) cohorts, both HIV positive and negative.

Characterization of Systemic and Local Immune Responses to Chlamydia Antigens in Women to support Vaccine Antigen Selection (The Chlamydia Study) (In collaboration with Merck)

The purpose of this study is to characterize the cellular and humoral immune responses to Chlamydia candidate antigens among women with protective immunity to Chlamydia vs. women susceptible for Chlamydia infection in order to support Chlamydia vaccine development.

The Effects of Opioid Use on HIV-1 Reservoir Dynamics: Opioids, HIV, and Translation Study (OPHION)

The objective of this study is to understand the effects of opioid use on HIV-1 latency. HIV latency is the residual virus remaining in people living with HIV, despite achieving HIV suppression via antiretroviral therapy. Although opioids have been shown to interact with HIV in laboratory experiments, we want to understand how opioids react with HIV in humans, and what health effects this may have.

In order to achieve these objectives we are collecting blood samples from approximately 120 patients from the BMC community, including those actively injecting opioid drugs, those on methadone or suboxone for the treatment of OUD, patients prescribed opioid drugs by their doctors, as well as people living with HIV who use no opioids.

Impact of Smoking and its Cessation on Systemic and Airway Immune Activation

Smoking is a major and urgent public health issue, especially for those living with HIV. Understanding the pathways by which smoking interacts with HIV-induced immune dysfunction in the lungs is critical to address this urgent public health concern. This project studies the immunological effects of smoking and quitting on lung health, and the ensuing change in HIV disease progression.

The purpose of this study is to learn how smoking affects the immune systems in people with HIV infection. We would like to know if HIV infected smokers who quit smoking have different responses in the lung and immune system from people who keep smoking.

RABIT: Rapid Bacterial Identification Study (sponsor Day Zero Diagnostics)

Bloodstream infections are one of the leading causes of morbidity and mortality in the United States. Rapid diagnosis is critical for improving survival, with an 8% rise in mortality for every hour that appropriate antibiotic treatment is delayed. However, the newest assays still either depend on a positive blood culture to initially isolate pathogenic bacteria, which takes at least 12-36 hours and fails in as many as 50% of cases of severe sepsis, or assess a very limited panel of pathogens

This study will evaluate the efficacy of a novel microbial whole genome sequencing (WGS) technique relative to traditional culture for pathogen identification and antimicrobial resistance (AMR) determination.

SOLAR (Switch Onto Long-Acting Regimen) (sponsored by ViiV)

People living with HIV undergo lifelong treatment with antiretroviral therapy (ART), in the form of fixed-dose combination pills taken orally. Taking ART daily is essential to achieve viral suppression and prevent the emergence of resistance mutations. Patients living with HIV and their physicians have observed that total pill burden, dosing frequency, and safety concerns are significant barriers to consistently adhering to their dosing schedules. Drug resistant HIV eventually emerges in most patients who struggle with medication adherence. Our goal is to test whether a long-acting injectable combination of cabotegravir-rilpivirine is as effective as taking the same medication orally.

Patients participating in SOLAR will receive an injection of study mediation every two months (60 days), or they will remain on oral ART (Biktarvy) for the 12-month duration of the study. Patients chosen to receive the study medication will be offered a choice to begin with an oral study medication before proceeding to the injectable (oral lead-in), or they may choose to receive the injectable right away (direct to inject).

During the study we will monitor participants to see if they maintain viral suppression, compare the efficacy and side effects of oral Biktarvy compared to the long-acting injectable, and assess participant satisfaction across both arms of the study.

Meet the Team

Nina Lin, MD

Dr. Nina Lin is a physician scientist engaged in HIV translational research. Her research is focused on understanding the effect of chronic HIV infection on aging of the immune system and chronic inflammation. She is the PI on several clinical trials, including being a co-Chair of ACTG A5325 and A5220s, to evaluate interventions which may improve or alter the clinical course of chronic HIV infection. Her research while at MGH/BWH had been on understanding HIV-1 coreceptor usage in subtype C infection and the factors associated with its switching. She is the Director of the BU Infectious Disease Clinical Research Unit (CRU) where several HIV and/or infectious diseases clinical studies are being conducted.

Archana Asundi, MD

Dr. Archana Asundi obtained her undergraduate degree from Tufts University and her medical degree from McGill University in Montreal, Canada. She then completed her internal medicine residency training at the Jewish General Hospital, as part of the McGill University Internal Medicine training program. Her areas of interest include HIV clinical research particularly related to aging-related comorbidities.

Dena Kivett, RN

Samantha Roche, RA

Yunhan Chen, RA

Athina Schmidt, RA

Margaret Pless, RA