Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, Prevention, Tenofovir, HIV Seronegativity
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.
Sites / Locations
- Thailand Ministry of Public Health - U.S. CDC Collaboration
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
tenofovir disoproxil fumarate
Placebo
Participants in the Tenofovir arm will receive daily oral tenofovir
Participants in the Placebo are will receive daily oral placebo