AIDS Research Alliance Facilities

Location and Organization

AIDS Research Alliance maintains a clinical research facility conducting clinical trials in all four phases of drug development, as well as the development of devices. AIDS Research Alliance was a leading site for the development of the OraQuick HIV test, with over 250 subjects tested. The clinic has 2 fully equipped BL-2 laboratories, 4 exam rooms, climate-controlled medication lockers and pharmacy, -70°C and –20°C freezers, temperature monitoring, and an automatic alarm system.

ARA is governed by a Board of Directors [Click here], composed of community and business leaders.  In addition, AIDS Research Alliance maintains a Scientific Advisory Committee (SAC) [click here] comprised of leading physicians, academic researchers and industry scientists, who advises the research staff ragarding on-going and potential clinical trials and our scientific agenda. AIDS Research Alliance maintains its own Institutional Review Board (IRB), [click here] including physicians and medical related professionals, whose sole job is to protect the rights of volunteers in clinical trials conducted at AIDS Research Alliance.  Volunteers who have participated in AIDS Research Alliance trials, community advocates and activists from deiverse racial and ethnic backgrounds comprise a recently formed Community Advisory Board (CAB) [Click here ].

Site Operations and Infrastructure

Communications

Regular, thorough and detailed communication is a standard operating procedure at ARA.  The Clinic’s weekly communications agenda includes: 1. Review of current and pending clinical trials. 2. Recruitment and enrollment process. 3. Adverse events and laboratory issues. 4. Regulatory issues and submissions. 5. Outreach and community education events and progress.

Once a protocol is approved, based on scientific and medical merits, diversity, and community interest, administrative staff prepares a cost analysis and clinic staff prepares protocols and other documents for submission to the AIDS Research Alliance IRB. Staff members are trained prior to enrollment for each study according to study protocol.

Data Management.

AIDS Research Alliance uses the HIPPA compliant software to track all patient contacts, schedule visits within the appropriate visit timeframe, track patient participation, generate study and visit specific checklists, and to ensure that important documents for IRB submission are preparred in a timely manner.

Regulatory Affairs

AIDS Research Alliance maintains its own Institutional Review Board (IRB) (Federal Wide Assurance Number: FWA00000941) whose sole job is to protect the rights of participants in clinical trials conducted in our clinic. A research Administratror is responsible for maintenance of the regulatory files for studies at AIDS Research Alliance and serves as the IRB Administrator.  In 1997 and 2005 an audit of the AIDS Research Alliance IRB by the Food and Drug Administration (FDA), and each audit resulted in a “no findings” report. 

Laboratory Capabilities

The AIDS Research Alliance Scientific Director supervises the activity of 2 fully equipped BL-2 laboratories.  A Clinical Research Assitant is responsible for the collection, storage and shipping of all required tests, and the processing of Peripheral Blood Mononuclear Cells (PBMCs) and DNA pellets. Routine safety tests, including hematology, chemistries, urinanalysis, and serology, are sent to the UCLA Medical Center.

Investigational Pharmacy

The medical research clinic at AIDS Research Alliance is responsible for the accurate accounting, storage and disposition of all investigational materials.  Medications and investigational materials are kept in a double-locked pharmacy.  Ambient refrigerator and freezer logs are kept for medications. Each year, pharmaceutical companies audit AIDS Research Alliance pharmacy procedures, which in all cases have been found to be consistent with Good Clinical Practices (GCP).

Relationship with other Laboratories

AIDS Research Alliance has established relationships with basic research laboratories and toxicology research groups for pre-clinical development and specialized endpoint measurements for clinical studies.

Patient Recruitment and Retention

The challenges in recruiting clinical trial participants and a finite supply of potential volunteers are the leading reasons for delay in the development of experimental drugs. AIDS Research Alliance’s ability to move promising new treatments and vaccines through the clinical trials process is at the core of our mission.  We are committed to accelerating the clinical development projects of our pharmaceutical partners with robust patient recruitment.

How we excel at patient recruitment:

• AIDS Research Alliance has a large in-house database of nearly 2000 patients specifically interested in participating in clinical trials of experimental HIV/AIDS drugs, preventative vaccines and microbicides.
• AIDS Research Alliance enjoys visibility and a sound reputation within the HIV community, thus we are able to avoid traditional barriers to clinical research, such as mistrust and fear of the unknown that are common to clinical studies.
• AIDS Research Alliance has a dedicated patient recruitment and community education staff. They continually build and reinforce personal relationships with referral sources such as HIV testing centers, private physicians, community clinics and HIV social service providers.
• AIDS Research Alliance uses culturally sensitive and appropriate advertising (when studies do not fully enroll from our in-house database).

Why AIDS Research Alliance has such a high rate of patient retention and compliance:

• AIDS Research Alliance builds supportive relationships with our patients

• Culturally-appropriate staff

• Our facility is centrally located and offers free parking

• AIDS Research Alliance offers transportation vouchers for patients who need assistance getting to the Clinic.

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