Status:
COMPLETED
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Ministry of Health, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
PHASE3
Brief 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 ...
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 conducte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
2413 Patients enrolled
Trial Details
Trial ID
NCT00119106
Start Date
June 1 2005
End Date
October 1 2014
Last Update
February 10 2021
Active Locations (1)
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1
Thailand Ministry of Public Health - U.S. CDC Collaboration
Nonthaburi, Thailand, 11000