Document 2289
 DOCN  M94A2289
 TI    The feasibility of vaccine efficacy trials in gay men and IDU's in the
       USA.
 DT    9412
 AU    Sheon A; Buchbinder S; Davenny K; Judson F; MacQueen K; McKiman D;
       Metzger D; Marmor M; Nelson K; Division of AIDS, NIAID, NIH, Rockville,
       MD 20892.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):338 (abstract no. PC0288). Unique
       Identifier : AIDSLINE ICA10/94370286
 AB    OBJECTIVES: Assess the feasibility of conducting Phase III efficacy
       trials of HIV vaccines in gay men and IDUs in the U.S.A. METHODS:
       Semi-annual and quarterly assessments of HIV serostatus, risk behaviors
       and attitudes toward HIV vaccine trials are conducted respectively among
       high risk gay/bisexual men in Chicago, Denver, and San Francisco, and
       among IDUs in Baltimore, Philadelphia, and New York. RESULTS: 2043
       gay/bi men and 1730 IDUs are followed in vaccine preparedness studies.
       Retention at 6 months ranged from 82-88% for gay men sites and 75-93%
       for IDU sites; at 12 months, IDU retention was 66-93%. Seroincidence
       ranged from 2-6/100 person years after 6 months of followup.
       Approximately one-half of participants are interested in joining an HIV
       vaccine efficacy trial, although many express concerns about potential
       side effects and about vaccine-induced seroconversions. Leading reasons
       for joining a trial include altruism and desire for self protection.
       DISCUSSION AND CONCLUSIONS: High risk cohorts have been recruited
       successfully for vaccine preparatory studies. Additional efforts will
       probably be needed to ensure adequate retention in vaccine trials. There
       is considerable willingness among gay men and among IDUs to participate
       in vaccine trials. However, because trials will be placebo controlled,
       and because the efficacy of the vaccine will be unknown, it will be
       important to counsel trial volunteers about the need to continue
       protecting themselves from HIV exposure if they join a trial.
 DE    Clinical Trials, Phase III  Cohort Studies  Feasibility Studies
       *Homosexuality  Human  HIV Infections/*PREVENTION & CONTROL/TRANSMISSION
       Knowledge, Attitudes, Practice  Male  Patient Acceptance of Health Care
       Risk Factors  Substance Abuse, Intravenous/*COMPLICATIONS/REHABILITATION
       United States  Urban Population  MEETING ABSTRACT

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