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.
Abstract
Background 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.Methods 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.Findings 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).Interpretation 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.Funding US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration.
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One clinical trial involving persons who inject drugs and one involving heterosexual mixed-status couples demonstrated substantial efficacy and safety of daily oral PrEP with TDF alone.
“In addition, one clinical trial involving persons who inject drugs (78) and one involving heterosexual mixed-status couples (76) demonstrated substantial efficacy and safety of daily oral PrEP with TDF alone.”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [78]
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- Authors
- Choopanya, K., Martin, M., Suntharasamai, P., Sangkum, U., Mock, P. A., Leethochawalit, M., Chiamwongpaet, S., Kitisin, P., Natrujirote, P., Kittimunkong, S., Chuachoowong, R., Gvetadze, R. J., McNicholl, J. M., Paxton, L. A., Curlin, M. E., Hendrix, C. W., & Vanichseni, S.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Ministry of Public Health (TH)
- Bangkok Metropolitan Administration (TH)
- Johns Hopkins University (US)
- Corresponding author
- Martin, Michael
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2013-06
- Volume
- 381
- Issue
- 9883
- Pages
- 2083-2090
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2000761749
- Cited by
- 1,463
- References
- 33
- Citations by year
- 2026: 41 · 2025: 82 · 2024: 83 · 2023: 78 · 2022: 110 · 2021: 123 · 2020: 112 · 2019: 113 · 2018: 126 · 2017: 117 · 2016: 166 · 2015: 148 · 2014: 125 · 2013: 36
- FWCI
- 115.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Gilead Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- HIV pre-exposure prophylaxis, tenofovir disoproxil fumarate, people who inject drugs, HIV prevention, HIV incidence, methadone treatment, HIV testing, risk reduction counseling, adverse events, nausea, Bangkok, Thailand, HIV prevention strategies, harm reduction, condom distribution, transfusion safety
- MeSH terms
- Tenofovir, Adenine, Adult, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Thailand, HIV Infections, Substance Abuse, Intravenous, Treatment Outcome, Anti-HIV Agents, Young Adult, Organophosphonates
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