JHU (Baltimore)

The Clinical Research Site at Johns Hopkins, directed by Yukari Manabe, MD, occupies space on  the East Baltimore Medical Campus. The JHU CRS takes advantage of the many units available within Johns Hopkins Hospital, including Inpatient/Overnight Services for adult research participants, the Outpatient Research Unit, Inpatient/Outpatient Service for pediatric research participants, research nutrition services, and the Drug Development and Analysis Unit.

The HIV Care Program serves as the most important resource for patient referrals to ACTG clinical trials, and is also an important referral source for HPTN trials. The Service is directed by Dr. Manabe, and was founded in 1983. The principal components are summarized below:

Laboratory Facilities
All sample processing for virology assays for the CRS will be performed in the HIV Specialty Lab and includes a tissue culture room, specimen prep room, a PCR amplification room, a room for HIV antibody testing and a PCR detection room. The HIV/STD Research Laboratory is recognized internationally for expertise as a reference laboratory for all STDs, especially gonorrhea and chlamydia testing. Both the gonococcal and chlamydial sections of this laboratory are licensed by the State of Maryland and Clinical Laboratory Improvement Amendments (CLIA; ID # 21D0680509; State of Maryland laboratory permit #008 and 940247, respectively) for STD diagnostic evaluations, and are recognized as leading diagnostic labs in the United States.

Clinical Trials

A5327: Sofosbuvir + Ribavirin w/o Interferon for Treatment...

A5327 SWIFT-C is a Phase I, open-label, two-cohort clinical trial, in which between 44 and 50 acutely HCV-infected HIV-1...

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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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A5302:  BioBank for Surrogate Marker Research for TB...

Primary Objective To obtain sputum, serum, urine, and peripheral blood mononuclear cells (PBMCs) for central TB biorepository...

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A5345, Identification of Biomarkers to Predict Time to...

Brief Summary: The purpose of this study is to collect information about what happens when people pause, or temporarily stop...

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A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

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