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.

AIDSTRIALS and AIDSDRUGS Searching

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 Criteria	General Inclusion Criteria: Patients must have: 1. HIV infection. 2. Acute cryptococcal meningitis.
Patient Age	Age: 18 - 99
Patient Sex	Male; Female
Patient Exclusion Criteria	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.

AIDSTRIALS and AIDSDRUGS Access

AIDSTRIALS and AIDSDRUGS are available free of charge on the NLM computer system, 24 hours a day, seven days a week. Interested users can access these files through the Internet using Internet Grateful Med®, a system developed by NLM to offer interactive, assisted searching for some of its databases. No password or account are required to use Internet Grateful Med. Registered NLM online services users can access AIDSTRIALS and AIDSDRUGS via modem using the FTS toll-free number (1-800-525-0216) or through the Internet (Telnet directly to medlars.nlm.nih.gov). 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).

Further 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
e-mail: aids@aids.nlm.nih.gov
URL: http://sis.nlm.nih.gov/aidswww.htm

For information on the Library's computerized information services, including AIDSTRIALS and AIDSDRUGS, contact:

National Library of Medicine
MEDLARS Management Section
8600 Rockville Pike
Bethesda, MD 20894
Telephone: 1-888-FINDNLM (1-888-346-3656) or (301) 594-5983
e-mail: mms@nlm.nih.gov