Journal Article

Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial

Chuachoowong, Rutt, Kitisin, Praphan, Vanichseni, Suphak, Suntharasamai, Pravan, Curlin, Marcel E, Hendrix, Craig W, Chiamwongpaet, Sithisat, Sangkum, Udomsak, Paxton, Lynn A, Martin, Michael, Gvetadze, Roman J, Kittimunkong, Somyot, Mock, Philip A, Choopanya, Kachit, Leethochawalit, Manoj, Natrujirote, Pitinan, McNicholl, Janet M

2013

Overview

Antiretroviral pre-exposure prophylaxis reduces sexual transmission of HIV. We assessed whether daily oral use of tenofovir disoproxil fumarate (tenofovir), an antiretroviral, can reduce HIV transmission in injecting drug users. In this randomised, double-blind, placebo-controlled trial, we enrolled volunteers from 17 drug-treatment clinics in Bangkok, Thailand. Participants were eligible if they were aged 20–60 years, were HIV-negative, and reported injecting drugs during the previous year. We randomly assigned participants (1:1; blocks of four) to either tenofovir or placebo using a computer-generated randomisation sequence. Participants chose either daily directly observed treatment or monthly visits and could switch at monthly visits. Participants received monthly HIV testing and individualised risk-reduction and adherence counselling, blood safety assessments every 3 months, and were offered condoms and methadone treatment. The primary efficacy endpoint was HIV infection, analysed by modified intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00119106. Between June 9, 2005, and July 22, 2010, we enrolled 2413 participants, assigning 1204 to tenofovir and 1209 to placebo. Two participants had HIV at enrolment and 50 became infected during follow-up: 17 in the tenofovir group (an incidence of 0·35 per 100 person-years) and 33 in the placebo group (0·68 per 100 person-years), indicating a 48·9% reduction in HIV incidence (95% CI 9·6–72·2; p=0·01). The occurrence of serious adverse events was much the same between the two groups (p=0·35). Nausea was more common in participants in the tenofovir group than in the placebo group (p=0·002). In this study, daily oral tenofovir reduced the risk of HIV infection in people who inject drugs. Pre-exposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs. US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Acquired immune deficiency syndrome / Adenine - analogs & derivatives / Adenine - therapeutic use / Adult / AIDS / Anti-HIV Agents - therapeutic use / Antibiotics. Antiinfectious agents. Antiparasitic agents / Antiretroviral agents / Antiviral agents / Biological and medical sciences / blood / Centers for Disease Control and Prevention / Community relations / Condoms / Consent / counseling / disease control / Disease transmission / Double-Blind Method / Female / Follow-Up Studies / General aspects / Hepatitis / HIV / HIV infections / HIV Infections - epidemiology / HIV Infections - prevention & control / Human immunodeficiency virus / Human viral diseases / Humans / Immunoassay / Infections / Infectious diseases / Internal Medicine / Male / Medical sciences / Mens health / methadone / Middle Aged / nausea / Organophosphonates - therapeutic use / Pharmacology. Drug treatments / Prevention / Prophylaxis / risk / risk reduction / safety assessment / Sexually transmitted diseases / STD / Substance abuse treatment / Substance Abuse, Intravenous - epidemiology / Tenofovir / Thailand / Thailand - epidemiology / Treatment Outcome / United States / Viral diseases / Viral diseases of the lymphoid tissue and the blood. Aids / volunteers / Womens health / Young Adult