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M94A2289.TXT
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1994-10-25
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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).