Document 1116
 DOCN  M94A1116
 TI    Phase I studies in anti-AIDS drugs and GCP.
 DT    9412
 AU    Lim C; Fourtillan JB; Chuan Lim Conseil, Sevres, France.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):205 (abstract no. PB0833). Unique
       Identifier : AIDSLINE ICA10/94371459
 AB    OBJECTIVES: Medical, nursing and laboratory staff called on to perform
       Phase I studies on potentially active compounds in the treatment of AIDS
       need to be protected from unnecessary risks all along the line from the
       seropositive subject to sample treatment and assays. International
       health regulatory authorities require that studies sponsored by
       pharmaceutical companies conform to Good Clinical Practice (GCP). We
       designed and set up a quality system of safety measures specifically for
       studies in seropositive subjects to prevent and deal with accidental
       contamination, based on epidemiological data on risk factors to
       personnel caring for AIDS patients and handling HIV infected biological
       samples. METHODS: Clinical and laboratory procedures were developed for
       examining subjects and handling plasma, serum and urine samples. The
       procedures were tested during a series of dry runs before the start of
       the study. RESULTS: No problems were met with after several studies
       carried out in a centre without any previous experience of handling HIV
       positive subjects and samples. DISCUSSION AND CONCLUSIONS: An essential
       factor in successfully carrying out these types of study was personnel
       training which allowed the identification and correction of possible
       incidents.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY/TRANSMISSION  *Clinical
       Trials, Phase I  Disease Transmission,
       Patient-to-Professional/*PREVENTION &  CONTROL  Human  *Universal
       Precautions  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).