Phase 3
Completed N=2,413
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
Source: ClinicalTrials.gov NCT00119106 ↗Enrolled (actual)
2,413
Serious AEs
19.6%
Results posted
Jan 2021
Primary outcomePrimary: Rates of HIV Seroconversion — 17; 33 Infections/ 100 person-years
◆ Published Evidence
Established
56citations · ~5 / year
Renal function of participants in the Bangkok tenofovir study--Thailand, 2005-2012.
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.
Linked Publications (5)
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Renal function of participants in the Bangkok tenofovir study--Thailand, 2005-2012.
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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.
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Enrollment characteristics and risk behaviors of injection drug users participating in the Bangkok Tenofovir Study, Thailand.
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Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand.
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Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of HIV Seroconversion |
17; 33 | — |
| PRIMARY Renal Toxicity |
3; 3 | — |
| PRIMARY Adverse Events |
1098; 1083 | — |
| SECONDARY Number of Participants Reporting Injecting and Sharing Needles |
58; 59 | — |
| SECONDARY Adherence to Study Drug/Placebo |
84; 84 | — |
| SECONDARY HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group |
929829; 120061 | — |
| SECONDARY Number Participants Who Reported More Than One Sexual Partner at Baseline |
251; 271 | — |
| SECONDARY Number of Participants With Tenofovir-associated Resistance Mutations. |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00119106) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.