AEGiS-13IAC: Baseline characteristics of injecting drug users (IDUs) enrolled in a phase III HIV vaccine efficacy trial - preliminary results from Bangkok, Thailand.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Baseline characteristics of injecting drug users (IDUs) enrolled in a phase III HIV vaccine efficacy trial - preliminary results from Bangkok, Thailand.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrD681)

Vanichseni S; S. Vanichseni, Bangkok Vaccine Evaluation Group, aksin Hospital, BVEG Office, 3rd Floor, 543 Somdej Choaphya Rd, Khet Klongsarn, Bangkok, 10600, Thailand, Tel.: +(662) 863-2121, Fax: +(662) 863-2129, E-mail: suphakv@dmc.inet.co.th

BACKGROUND: Since 1988, IDUs in Bangkok have experienced a severe epidemic of HIV infection with a sustained annual incidence rate of 6%. Previous studies have suggested that this population is highly motivated to participate in HIV vaccine trials. In March 1999, a phase III trial was initiated among 2500 IDUs to evaluate the protective efficacy of bivalent B/E rgp120 HIV vaccine (AIDSVAX(tm) B/E). An important outcome of this trial is the first description of baseline characteristics of this high-risk group participating in the first international phase III HIV vaccine efficacy trial.

METHODS: At enrollment into the trial, standardized questionnaires were used to interview IDUs on demographics, risk behavior, and motivations and reasons for participating in the trial.

RESULTS: As of 17 January 2000, 1304 IDUs have been enrolled. The volunteers are mostly male (93%), Thai (99%), young (mean age 30.6 yr.), have at least primary education (94%), and have been incarcerated in the past (15%). Almost all (99.7%) inject heroin on a regular (30%) or sporadic (70%) basis, and 30% have reported sharing needles. The primary reasons or motivations to participate in this trial are altruistic with 96% wanting to do something to stop the spread of HIV. Thus far, loss to follow-up has been minimal (0.5%) and immunization compliance has been 100%.

CONCLUSIONS: IDUs in Bangkok continue to be at high risk of HIV infection and appear to be highly motivated to enroll and participate in this first international phase III efficacy trial. Results of this trial will provide important information on the protective efficacy of AIDSVAX B/E vaccine against parenteral HIV infection.

Keywords: AEGIS, AIDS Vaccines, Clinical Trials, Needle Sharing, HIV Infections, Thailand, Risk-Taking, Incidence, Glass Ionomer Cements, HIV Seropositivity, Patient Compliance, AIDSVAX, BaseLine, Male
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ThOrD681