Founded in 1989, AIDS Research Alliance (ARA) is a non-profit medical research organization dedicated to the discovery and development of promising new treatments and prevention strategies (including vaccines and microbicide) for HIV/AIDS, with a cure for AIDS as its ultimate goal.

For many of the large HIV/AIDS drug development companies, ARA is a leading clinical research organization with a proven track record for extremely rapid patient enrollment (even for hard-to-reach groups such as treatment-naïve patients and minorities) and exceptional data collection.

As a not-for-profit organization, ARA contains study costs while ensuring the seamless implementation of clinical studies, and is uniquely positioned to meet the needs of HIV/AIDS drug development companies. Speeding up study implementation, enrollment and completion without compromising data integrity is an ARA hallmark.

ARA is a full-service contract research organization, or CRO, for companies engaged in HIV and AIDS-related drug development. These services have grown to include critical-path-to-market analysis, pre-clinical consulting and strategy, clinical protocol design and writing, case report form (CRF) design, regulatory affairs, data management, biostatistical design/analysis and study report writing.

• Phase I-IV
• First-in-Man Studies
• Pharmacokinetics
• Drug Interaction Studies
• In-Patient Studies
• Neurological Studies

Project Management and Support Services

• Regulatory Affairs
• Pre-Clinical Development
• Study Design & Protocol Writing
• CRF Design and Development
• Data Management
• Biostatistics

Partial lists of pharmaceutical companies: Agouron Pharmaceuticals, Pfizer, Bristol-Meyers Squibb, Gilead sciences, Inc., GlaxoWelcome, VaxGen, Inc, Merck, Theratechnology, Tibotech, Shaman Pharmaceuticals, Pharmacia & Upjohn, etc

Location and Organization

ARA maintains an 8800 square foot clinical research facility conducting clinical trials in all four Phases of drug development, as well as development of devices, (e.g. ARA was a major site for the development of the OraQuick HIV test with over 250 subjects tested). The clinic site has 2 fully equipped BL-2 laboratories, 4 exam rooms, climate-controlled medication lockers and pharmacy, 20&degC and -70&degC freezers, temperature monitoring, and an automatic alarm system. In addition multilingual (English, Spanish, French) staff and HIV counseling are available.

Site Operation and Infrastructure
Data Management System

ARA uses the HIPPA compliant Study Manager? to track all patient contacts, schedule visits within the appropriate visit window or timeframe, to track patient participation, generate study and visit specific checklists, and to ensure important documents for IRB submission are submitted in a timely manner.

Regulatory

ARA maintains its own IRB (Federal Wide Assurance Number: FWA00000941) whose sole job is to protect the rights of volunteers in ARA protocols. In 1997, an audit of the ARA IRB by the Food and Drug Administration (FDA) resulted in a "no findings" report.

Laboratory Capabilities

Dr. Hezareh supervises the activity of 2 fully equipped BL-2 laboratories at ARA. Mr. Castro is responsible for the collection, login, processing, storage and shipping of all required tests. In addition, he processes Peripheral Blood Mononuclear cells (PBMCs) and DNA pellets. Routine safety tests including hematology, chemistries, urinanalysis, and serology will be sent to the UCLA Medical Center. Because of the importance of correct timing and handling of blood during the preparation of PBMCs and DNA pellets, we have decided that the ARA laboratory will serve as a backup for the UCLA CARE Clinic CRS laboratory.

Investigational Pharmacy

ARA staff is responsible for the accurate accounting, storage and disposition of all investigational materials. Medications and investigational materials are kept in a double locked pharmacy room. Ambient refrigerator and freezer logs are kept for all medications. Each year, pharmaceutical companies audit ARA pharmacy procedures, which have been found to be consistent with Good Clinical Practices (GCP).

Stephen J. Brown, M.D.
Medical Director

Marjan Hezareh, PhD.
Scientific Director

Seymour Young, M.D.
Neurology

Robert Winter, M.D.
Interim Associate Medical Director

Michele Vertucci, PA-C
Clinic Manager

Corie Castro
Clinical Research Assistant

Krystle Zeibell
Clinical Research Assistant

ARA has access to over 10,000 HIV+ individuals through affiliation with community organizations and local primary care providers. ARA maintains an in-house patient database with over 2000 well-characterized HIV positive and negative volunteers. We endeavor to reflect both the ethnic and gender diversity of HIV.

Contact Information

AIDS Research Alliance

621-A N. San Vicente Boulevard
Los Angeles, CA 90069 USA
Phone: 310-358-2423
Fax: 310-358-2431
E-mail:

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