HIV InfectionsPhase 2/3NCT00119106
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
A Phase 2/3 study testing Tenofovir disoproxil in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir disoproxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,413 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2005to Oct 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Report injection drug use in the 6 months before screening
- Possess a Thai National Identification Card
- Laboratory values as follows within 2 weeks before enrollment:
- HIV oral fluid test non-reactive at screening and pre-enrollment visits
- Hemoglobin 9 gm/dL
- ALT and AST 2.5 x upper limit of normal (ULN)
Show all 14Show fewer
- Total bilirubin 1.5 mg/dL
- Serum amylase 1.5 x ULN
- Serum phosphorus 2.2 mg/dL
- No evidence of current or chronic Hepatitis B infection by serology
- Calculated creatinine clearance 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = Male: (140 - age in years) x (wt in kg)/72 x (serum creatinine in mg/dL) Female:(140 - age in years) x (wt in kg) x 0.85/72 x (serum creatinine in mg/dL)
- Willing to abstain from sexual intercourse or use effective contraception during the trial (oral, injection, or barrier), for women
- Willing and able to provide informed consent for study participation
- Available and committed to DOT or monthly follow-up for at least 12 months
Who cannot join
- Clinic physicians will determine if a subject with chronic illness requiring prescription medication can not enroll (medication used for drug treatment is allowed)
- Positive urine pregnancy test
- Breastfeeding
- History of significant renal, liver, or bone disease
- Any other clinical condition or prior therapy that, in the opinion of the clinic physician, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- Concurrent participation in any other HIV prevention trial or drug/vaccine safety trial. AIDSVAX B/E HIV vaccine trial (CDC protocol #2076) participants and Extension Study (CDC protocol #3750) participants may be screened for enrollment in the Bangkok Tenofovir Study.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thailand Ministry of Public Health - U.S. CDC Collaboration
Nonthaburi, 11000
About this study
Official title: Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand
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.
Read the detailed description
This is a phase II/III, randomized, double-blind, placebo-controlled study of the safety and efficacy of chemoprophylactic tenofovir, administered orally once daily to IDUs. The study will be conducted in Bangkok at 17 BMA Drug Treatment Clinics. Study participants will be randomized (1:1) to receive tenofovir 300 mg or placebo. Participants will be evaluated for adverse events and HIV seroconversion.
Primary endpoints: The primary efficacy endpoint will be measured by rates of HIV seroconversion measured at monthly intervals. The primary safety endpoints will be measured by the frequency of Grade 3 or 4 renal or hepatic function laboratory toxicities or clinical toxicities in blinded tenofovir and placebo arms, as defined by the Gilead-modified NIAID Adult Common Toxicity Tables, and which cannot be directly attributed to a cause other than study medications; and the frequency of adverse clinical events in tenofovir and placebo arms.
Secondary endpoints: Changes in HIV associated risk behaviors will be measured by rates of reported injection drug use and injection drug use frequency during the trial; rates of reported needle sharing; the number of unprotected sexual acts over the course of the trial; number of reported sexual partners over the course of the trial; and proportional use of condoms during sexual intercourse.
Medication adherence will be measured as: rates, by interview and documentation on tenofovir adherence card, of participants taking at least six (86%) of seven daily doses of study drug each of the four weeks preceding the monthly study visit. Differences in virologic and immunologic responses to HIV infection among tenofovir and placebo recipients will be measured by: plasma viral load, measured by quantitative RNA PCR, a predictor of clinical progression of HIV disease; 14 CD4 cell counts will be measured by flow cytometry. Rates and nature of HIV antiretroviral genotypic and phenotypic resistance will be measured. Genetic characteristics of infecting HIV viruses including DNA sequence analysis and antibody binding studies will be conducted.
In phase II, participants will be followed months 0, 1, 2, 3, then 3 monthly with hematology and chemistry tests and laboratory evaluations of renal and hepatic function until 200 person-years of observation are accrued. At that point, a DSMB safety assessment will be conducted. Follow-up of enrolled participants will continue during the DSMB safety assessment. If safety is confirmed, all phase II participants will continue, and additional participants will be enrolled into the phase III portion of the trial. Accrual of the target enrollment of 2,400 IDUs is anticipated to take 48 months.
Participants will choose between two follow-up schedules: monthly (every 4 weeks) or monthly plus daily with directly observed therapy (DOT). During DOT visits clinic staff will witness the participant swallow his/her study medication and clinic staff will initial the participant's tenofovir adherence card. Monthly visits will be the same for both groups and will include an assessment of tenofovir adherence and adverse events, a pill count and collection of unused pills, provision of a new 1 month supply of study medication, pre- and post-test HIV counseling, rapid oral HIV testing, urine pregnancy test (for female participants), HIV risk reduction counseling, and medication adherence counseling. At 3, 6, and every 3 months thereafter monthly procedures will be supplemented with a risk behavior questionnaire.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil, Placebo
- Keywords
- HIV, Prevention, Tenofovir, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxilDrug
Also called Tenofovir
Antiretroviral
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| tenofovir disoproxil fumarate | Experimental | Participants in the Tenofovir arm will receive daily oral tenofovir Receives: Drug: Tenofovir disoproxil |
| Placebo | Placebo comparator | Participants in the Placebo are will receive daily oral placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of HIV Seroconversion
Kaplan Meier survival curve.
Measured: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years
Renal Toxicity
Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities
Measured: Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years
Adverse Events
Number of Participants with adverse clinical events in tenofovir and placebo arms
Measured: Up to 6.9 years
Secondary outcomes (5)
Number of Participants Reporting Injecting and Sharing Needles
Number of Participants reporting injecting and sharing needles:
Assessed injecting and sharing at baseline and every 3 months during follow-up. We used GEE to determine if there was a significant decline in injecting and sharing.
Measured: Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years
Adherence to Study Drug/Placebo
Mean number of days that participants took study drug based on study drug diaries by study group.
Measured: Participants were asked about adherence at 3 month visits, up to 6.9 years.
HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group
Plasma HIV RNA concentrations.
Measured: Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion
Number Participants Who Reported More Than One Sexual Partner at Baseline
Number of participants
Measured: At enrolment
Number of Participants With Tenofovir-associated Resistance Mutations.
Measure tenofovir associated resistance mutations (ie, K65R and K70E) in amplified viral RNA specimens from HIV-positive participants in the placebo and tenofovir groups.
Measured: Specimens collected at the time of HIV seroconversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionJul 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Thailand, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Responsible party
- Sponsor
- Investigators
- Kachit Choopanya, MD, Principal investigator, Bangkok Tenofovir Study GroupMichael T Martin, MD, MPH, Study director, Centers for Disease Control and PreventionLynn Paxton, MD, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119106
- Sponsor's protocol ID
- CDC-NCHSTP-4370
- Status last verified
- Feb 2015
- First submitted
- 8 Jul 2005
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Concept sheets are reviewed and approved, modified, or declined by research team.
Publications
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.
PubMed 23769234Martin 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.
PubMed 27866873Martin 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.
PubMed 25985403Martin 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.
PubMed 24667938Vanichseni 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.
PubMed 25880964Parker 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.
PubMed 33126825Suntharasamai 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.
PubMed 26717405Martin 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.
PubMed 24829212Martin 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.
PubMed 21969870
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand
- ClinicalTrials.gov ID
- NCT00119106
- Acronym / sponsor ID
- CDC-NCHSTP-4370
- Conditions
- HIV Infections
- Keywords
- HIV, Prevention, Tenofovir, HIV Seronegativity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,413 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Thailand, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Study start
- Jun 2005
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Jul 2005 (estimated)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II/III, randomized, double-blind, placebo-controlled study of the safety and efficacy of chemoprophylactic tenofovir, administered orally once daily to IDUs. The study will be conducted in Bangkok at 17 BMA Drug Treatment Clinics. Study participants will be randomized (1:1) to receive tenofovir 300 mg or placebo. Participants will be evaluated for adverse events and HIV seroconversion.
Primary endpoints: The primary efficacy endpoint will be measured by rates of HIV seroconversion measured at monthly intervals. The primary safety endpoints will be measured by the frequency of Grade 3 or 4 renal or hepatic function laboratory toxicities or clinical toxicities in blinded tenofovir and placebo arms, as defined by the Gilead-modified NIAID Adult Common Toxicity Tables, and which cannot be directly attributed to a cause other than study medications; and the frequency of adverse clinical events in tenofovir and placebo arms.
Secondary endpoints: Changes in HIV associated risk behaviors will be measured by rates of reported injection drug use and injection drug use frequency during the trial; rates of reported needle sharing; the number of unprotected sexual acts over the course of the trial; number of reported sexual partners over the course of the trial; and proportional use of condoms during sexual intercourse.
Medication adherence will be measured as: rates, by interview and documentation on tenofovir adherence card, of participants taking at least six (86%) of seven daily doses of study drug each of the four weeks preceding the monthly study visit. Differences in virologic and immunologic responses to HIV infection among tenofovir and placebo recipients will be measured by: plasma viral load, measured by quantitative RNA PCR, a predictor of clinical progression of HIV disease; 14 CD4 cell counts will be measured by flow cytometry. Rates and nature of HIV antiretroviral genotypic and phenotypic resistance will be measured. Genetic characteristics of infecting HIV viruses including DNA sequence analysis and antibody binding studies will be conducted.
In phase II, participants will be followed months 0, 1, 2, 3, then 3 monthly with hematology and chemistry tests and laboratory evaluations of renal and hepatic function until 200 person-years of observation are accrued. At that point, a DSMB safety assessment will be conducted. Follow-up of enrolled participants will continue during the DSMB safety assessment. If safety is confirmed, all phase II participants will continue, and additional participants will be enrolled into the phase III portion of the trial. Accrual of the target enrollment of 2,400 IDUs is anticipated to take 48 months.
Participants will choose between two follow-up schedules: monthly (every 4 weeks) or monthly plus daily with directly observed therapy (DOT). During DOT visits clinic staff will witness the participant swallow his/her study medication and clinic staff will initial the participant's tenofovir adherence card. Monthly visits will be the same for both groups and will include an assessment of tenofovir adherence and adverse events, a pill count and collection of unused pills, provision of a new 1 month supply of study medication, pre- and post-test HIV counseling, rapid oral HIV testing, urine pregnancy test (for female participants), HIV risk reduction counseling, and medication adherence counseling. At 3, 6, and every 3 months thereafter monthly procedures will be supplemented with a risk behavior questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenofovir disoproxil fumarate | Experimental | Drug: Tenofovir disoproxilParticipants in the Tenofovir arm will receive daily oral tenofovir |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in the Placebo are will receive daily oral placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Report injection drug use in the 6 months before screening
- Possess a Thai National Identification Card
- Laboratory values as follows within 2 weeks before enrollment:
- HIV oral fluid test non-reactive at screening and pre-enrollment visits
- Hemoglobin 9 gm/dL
Key exclusion criteria (6 listed)
- Clinic physicians will determine if a subject with chronic illness requiring prescription medication can not enroll (medication used for drug treatment is allowed)
- Positive urine pregnancy test
- Breastfeeding
- History of significant renal, liver, or bone disease
- Any other clinical condition or prior therapy that, in the opinion of the clinic physician, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxilAlso: TenofovirAntiretroviral | Drug | tenofovir disoproxil fumarate |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Rates of HIV Seroconversion
Time frame: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years
Kaplan Meier survival curve.
Renal Toxicity
Time frame: Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years
Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities
Adverse Events
Time frame: Up to 6.9 years
Number of Participants with adverse clinical events in tenofovir and placebo arms
5 secondary outcomes
Number of Participants Reporting Injecting and Sharing Needles
Time frame: Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years
Adherence to Study Drug/Placebo
Time frame: Participants were asked about adherence at 3 month visits, up to 6.9 years.
HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group
Time frame: Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion
Number Participants Who Reported More Than One Sexual Partner at Baseline
Time frame: At enrolment
Number of Participants With Tenofovir-associated Resistance Mutations.
Time frame: Specimens collected at the time of HIV seroconversion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23769234Choopanya 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: PubMed 27866873Martin 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: PubMed 25985403Martin 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: PubMed 24667938Martin 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: PubMed 25880964Vanichseni 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.
- Derived from this study: PubMed 33126825Parker 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.
- Derived from this study: PubMed 26717405Suntharasamai 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.
- Derived from this study: PubMed 24829212Martin 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.
- Derived from this study: PubMed 21969870Martin 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.
- Individual participant dataSharing planned: Yes. Concept sheets are reviewed and approved, modified, or declined by research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kachit Choopanya, MD principal investigator
Bangkok Tenofovir Study Group
Michael T Martin, MD, MPH study director
Centers for Disease Control and Prevention
Lynn Paxton, MD study director
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tenofovir disoproxil in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of HIV Seroconversion (time frame: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119106, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.