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

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

Research output: Contribution to journalArticle

670 Citations (Scopus)

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 off ered condoms and methadone treatment. The primary effi cacy endpoint was HIV infection, analysed by modifi ed 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. Preexposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs.

Original languageEnglish (US)
Pages (from-to)2083-2090
Number of pages8
JournalThe Lancet
Volume381
Issue number9883
DOIs
StatePublished - 2013
Externally publishedYes

Fingerprint

Tenofovir
Thailand
Drug Users
HIV Infections
Placebos
HIV
Pharmaceutical Preparations
Blood Safety
Intention to Treat Analysis
Methadone
Incidence
Condoms
Risk Reduction Behavior
Random Allocation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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

In: The Lancet, Vol. 381, No. 9883, 2013, p. 2083-2090.

Research output: Contribution to journalArticle

Choopanya, K, Martin, M, Suntharasamai, P, Sangkum, U, Mock, PA, Leethochawalit, M, Chiamwongpaet, S, Kitisin, P, Natrujirote, P, Kittimunkong, S, Chuachoowong, R, Gvetadze, RJ, McNicholl, JM, Paxton, LA, Curlin, M, Hendrix, CW & Vanichseni, S 2013, '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', The Lancet, vol. 381, no. 9883, pp. 2083-2090. https://doi.org/10.1016/S0140-6736(13)61127-7
Choopanya, Kachit ; Martin, Michael ; Suntharasamai, Pravan ; Sangkum, Udomsak ; Mock, Philip A. ; Leethochawalit, Manoj ; Chiamwongpaet, Sithisat ; Kitisin, Praphan ; Natrujirote, Pitinan ; Kittimunkong, Somyot ; Chuachoowong, Rutt ; Gvetadze, Roman J. ; McNicholl, Janet M. ; Paxton, Lynn A. ; Curlin, Marcel ; Hendrix, Craig W. ; Vanichseni, Suphak. / 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. In: The Lancet. 2013 ; Vol. 381, No. 9883. pp. 2083-2090.
@article{2a0a454bf1754903ace6cd9e97188622,
title = "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 off ered condoms and methadone treatment. The primary effi cacy endpoint was HIV infection, analysed by modifi ed 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. Preexposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs.",
author = "Kachit Choopanya and Michael Martin and Pravan Suntharasamai and Udomsak Sangkum and Mock, {Philip A.} and Manoj Leethochawalit and Sithisat Chiamwongpaet and Praphan Kitisin and Pitinan Natrujirote and Somyot Kittimunkong and Rutt Chuachoowong and Gvetadze, {Roman J.} and McNicholl, {Janet M.} and Paxton, {Lynn A.} and Marcel Curlin and Hendrix, {Craig W.} and Suphak Vanichseni",
year = "2013",
doi = "10.1016/S0140-6736(13)61127-7",
language = "English (US)",
volume = "381",
pages = "2083--2090",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9883",

}

TY - JOUR

T1 - Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study)

T2 - A randomised, double-blind, placebo-controlled phase 3 trial

AU - Choopanya, Kachit

AU - Martin, Michael

AU - Suntharasamai, Pravan

AU - Sangkum, Udomsak

AU - Mock, Philip A.

AU - Leethochawalit, Manoj

AU - Chiamwongpaet, Sithisat

AU - Kitisin, Praphan

AU - Natrujirote, Pitinan

AU - Kittimunkong, Somyot

AU - Chuachoowong, Rutt

AU - Gvetadze, Roman J.

AU - McNicholl, Janet M.

AU - Paxton, Lynn A.

AU - Curlin, Marcel

AU - Hendrix, Craig W.

AU - Vanichseni, Suphak

PY - 2013

Y1 - 2013

N2 - 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 off ered condoms and methadone treatment. The primary effi cacy endpoint was HIV infection, analysed by modifi ed 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. Preexposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs.

AB - 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 off ered condoms and methadone treatment. The primary effi cacy endpoint was HIV infection, analysed by modifi ed 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. Preexposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs.

UR - http://www.scopus.com/inward/record.url?scp=84879000125&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879000125&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(13)61127-7

DO - 10.1016/S0140-6736(13)61127-7

M3 - Article

C2 - 23769234

AN - SCOPUS:84879000125

VL - 381

SP - 2083

EP - 2090

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9883

ER -