AIDSTRIALS AND AIDSDRUGS

AIDSTRIALS AND AIDSDRUGS DEFINED

The AIDSTRIALS (AIDS Clinical Trials) database provides information about AIDS-related studies of experimental treatments conducted under the Food and Drug Administration's (FDA) investigational new drug (IND) regulations. AIDSTRIALS contains information about clinical trials of agents undergoing evaluation for use against Acquired Immunodeficiency Syndrome (AIDS), HIV infection and AIDS-related opportunistic diseases such as Pneumocystis carinii pneumonia (PCP). Detailed information is supplied by the National Institute for Allergy and Infectious Diseases (NIAID) for trials sponsored by the National Institutes of Health (NIH). Information about non-NIH funded trials undergoing tests for efficacy is furnished by FDA. The companion database, AIDSDRUGS, contains descriptive information about the agents being tested in clinical trials.

ACCESS

AIDSTRIALS and AIDSDRUGS can be accessed by a variety of terminals connected to NLM's computer facility. Connection is established via direct telephone line; the TELENET/SprintNet, TYMNET, or CompuServe nationwide telecommunications networks; or by the Internet at medlars.nlm.nih.gov .

SEARCHING AIDSTRIALS AND AIDSDRUGS

The information contained in AIDSTRIALS includes the title of the trial, the trial purpose, the agent being tested, the trial phase, diseases studied, patient inclusion and exclusion criteria, trial locations, and whether the trial is open or closed; details of the treatment regimen may also be included. The file may be used to identify trials testing a particular agent or to find open trials in a specific location. If additional information is required about the trial, all records contain a telephone number for contacting the specific trial site or sponsor. If additional information about the agent being tested is required, the AIDSDRUGS database may be searched using either the drug name, accession number contained in the trial record, or the number of the protocol. AIDSDRUGS may be searched to find out about a new drug, then AIDSTRIALS accessed to search for trials using that drug. The following represents portions of an AIDSTRIALS record:

UNIQUE IDENTIFIER         FDA/00535
PROTOCOL ID NUMBERS       FDA 131A
PROTOCOL TITLE            Phase I study to evaluate the safety
                          and tolerance of RMP-7 administered
                          with amphotericin B to patients with
                          HIV infection and cryptococcal
                          meningitis.
GENERAL DESCRIPTION       To evaluate the safety of escalating
                          doses of RMP-7 administered in persons
                          with HIV infection and cryptococcal
                          meningitis and to determine the MTD of
                          the drug.
OPEN/CLOSED INDICATOR     Open: actively accruing patients
                          (930301).
DISEASE STUDIED           Cryptococcal meningitis.
PATIENT INCLUSION CRIT.   GENERAL INCLUSION CRITERIA:  Patients
                          must have: 1. HIV infection. 2. Acute
                          cryptococcal meningitis.
PATIENT AGE               AGE: 18 - 99
PATIENT SEX               MALE ; FEMALE
PATIENT EXCLUSION CRIT.   GENERAL EXCLUSION CRITERIA: Patients
                          with the following prior conditions are
                          excluded: 1. History of bleeding
                          disorder. 2. History of active renal or
                          hepatic disease...
SUBSTANCE IDENTIFICATION  Drug 1: DRG-0182: RMP-7
                          Drug 2: DRG-0006: Amphotericin B
LOCATION OF TRIAL         Los Angeles County / USC Medical Center
                          1200 North State Street, Los Angeles,
                          CA 90033; Contact: DeAnn Diamond (213)
                          226-3695 OPEN 930301...
SUPPORTING AGENCY         Alkermes Incorporated.
MESH                      Acquired Immunodeficiency
                          Syndrome/complications; Adult; Aged;
                          Amphotericine
                          B/*pharmacokinetics/toxicity;...
ENTRY MONTH               9307

After a search of AIDSTRIALS, a user may switch to the AIDSDRUGS database and view descriptive information about the agent used in the clinical trial, such as synonyms for the name including trade names, the standard chemical name, pharmacology, contraindications, adverse reactions, manufacturer, and physical/chemical properties such as molecular composition, formula and weight. It is easy to coordinate searches between databases since the substance identification number from AIDSDRUGS is present in the AIDSTRIALS record and the protocol numbers from AIDSTRIALS are carried in AIDSDRUGS. As new trials are added to AIDSTRIALS, information will be compiled about the agents and records added to AIDSDRUGS.

AVAILABILITY

There is no charge for searching AIDSTRIALS and AIDSDRUGS. Both databases are available 24 hours a day, 7 days a week. The entire AIDSDRUGS database and AIDSTRIALS records describing open studies are also available via FTP from the NLM Publications server (nlmpubs.nlm.nih.gov; login as nlmpubs).

ADDITIONAL INFORMATION

For information about AIDSTRIALS and AIDSDRUGS content and search strategies contact:

Specialized Information Services
National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894

Telephone: (301) 496-3147

Fax: (301) 480-3537

Internet Address: toxmail@nlm.nih.gov

For information on additional MEDLARS services contact:

National Library of Medicine
MEDLARS Management Section
8600 Rockville Pike
Bethesda, MD 20894

Telephone: 1-800-638-8480

Internet Address: mms@nlm.nih.gov

NLM HyperDOC / AIDSTRIALS and AIDSDRUGS FactSheet / March 1994