drugset / Trial / NCT00119106
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
Phase 2/3
Completed
2413 enrolled
Centers for Disease Control and Prevention
Bangkok Metropolitan Administration Medical College and Vajira Hospital · collabMinistry of Health, Thailand · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in HIV associated risk behaviors, adherence to study drug, and, among IDU who become HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic characterization of infecting HIV viruses, and antiretroviral resistance will also be done.
Timeline
- Start
- 2005-06
- Primary completion
- 2013-07
- Completion
- 2014-10
Publications
- Background 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 ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. 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. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
- Background Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Chaipung B, Worrajittanon D, Leethochawalit M, Chiamwongpaet S, Kittimunkong S, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Holtz TH, Samandari T, Choopanya K; Bangkok Tenofovir Study Group. Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study. Lancet HIV. 2017 Feb;4(2):e59-e66. doi: 10.1016/S2352-3018(16)30207-7. Epub 2016 Nov 18.
- Background Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Curlin ME, Na-Pompet S, Warapronmongkholkul A, Kittimunkong S, Gvetadze RJ, McNicholl JM, Paxton LA, Choopanya K; Bangkok Tenofovir Study Group. The impact of adherence to preexposure prophylaxis on the risk of HIV infection among people who inject drugs. AIDS. 2015 Apr 24;29(7):819-24. doi: 10.1097/QAD.0000000000000613.
- Background Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Gvetadze RJ, Kittimunkong S, Curlin ME, Worrajittanon D, McNicholl JM, Paxton LA, Choopanya K; Bangkok Tenofovir Study Group. Risk behaviors and risk factors for HIV infection among participants in the Bangkok tenofovir study, an HIV pre-exposure prophylaxis trial among people who inject drugs. PLoS One. 2014 Mar 25;9(3):e92809. doi: 10.1371/journal.pone.0092809. eCollection 2014.
- Background Vanichseni S, Martin M, Suntharasamai P, Sangkum U, Mock PA, Gvetadze RJ, Curlin ME, Leethochawalit M, Chiamwongpaet S, Chaipung B, McNicholl JM, Paxton LA, Kittimunkong S, Choopanya K. High Mortality Among Non-HIV-Infected People Who Inject Drugs in Bangkok, Thailand, 2005-2012. Am J Public Health. 2015 Jun;105(6):1136-41. doi: 10.2105/AJPH.2014.302473. Epub 2015 Apr 16.
- Parker I, Khalil G, Martin A, Martin M, Vanichseni S, Leelawiwat W, McNicholl J, Hickey A, Garcia-Lerma JG, Choopanya K, Curtis KA. Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis. AIDS Res Hum Retroviruses. 2021 Mar;37(3):189-195. doi: 10.1089/AID.2020.0137. Epub 2020 Dec 9.
- Suntharasamai P, Martin M, Choopanya K, Vanichseni S, Sangkum U, Tararut P, Leelawiwat W, Anekvorapong R, Mock PA, Cherdtrakulkiat T, Leethochawalit M, Chiamwongpaet S, Gvetadze RJ, McNicholl JM, Paxton LA, Kittimunkong S, Curlin ME. Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand. PLoS One. 2015 Dec 30;10(12):e0145859. doi: 10.1371/journal.pone.0145859. eCollection 2015.
- Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Gvetadze RJ, Curlin ME, Leethochawalit M, Chiamwongpaet S, Cherdtrakulkiat T, Anekvorapong R, Leelawiwat W, Chantharojwong N, McNicholl JM, Paxton LA, Kittimunkong S, Choopanya K; Bangkok Tenofovir Study Group. Renal function of participants in the Bangkok tenofovir study--Thailand, 2005-2012. Clin Infect Dis. 2014 Sep 1;59(5):716-24. doi: 10.1093/cid/ciu355. Epub 2014 May 14.
- Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Chuachoowong R, Mock PA, Leethochawalit M, Chiamwongpaet S, Kittimunkong S, van Griensven F, McNicholl JM, Paxton L, Choopanya K; Bangkok Tenofovir Study Group. Enrollment characteristics and risk behaviors of injection drug users participating in the Bangkok Tenofovir Study, Thailand. PLoS One. 2011;6(9):e25127. doi: 10.1371/journal.pone.0025127. Epub 2011 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |