Bangkok Tenofovir Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Health, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00119106
First received: July 8, 2005
Last updated: September 10, 2012
Last verified: September 2012

July 8, 2005
September 10, 2012
June 2005
July 2010   (final data collection date for primary outcome measure)
  • Adverse events [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • rates of HIV seroconversion measured at monthly intervals [ Time Frame: until end of trial ] [ Designated as safety issue: No ]
  • the frequency of Grade 3 or 4 renal or hepatic function laboratory toxicities or clinical toxicities in blinded tenofovir and placebo arms and which cannot be directly attributed to a cause other than study medications [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • the frequency of adverse clinical events in tenofovir and placebo arms [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • Adverse events
  • rates of HIV seroconversion measured at monthly intervals
  • the frequency of Grade 3 or 4 renal or hepatic function laboratory toxicities or clinical toxicities in blinded tenofovir and placebo arms and which cannot be directly attributed to a cause other than study medications
  • the frequency of adverse clinical events in tenofovir and placebo arms
Complete list of historical versions of study NCT00119106 on ClinicalTrials.gov Archive Site
  • Rates of injecting and needle sharing [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • adherence to study drug/placebo [ Time Frame: until end of trial ] [ Designated as safety issue: No ]
  • HIV viral load and CD4 counts [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • antiretroviral resistance [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • genetic characteristics of infecting [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • the number of unprotected sexual acts over the course of the trial [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • number of reported sexual partners over the course of the trial [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • proportional use of condoms during sexual intercourse [ Time Frame: until end of trial ] [ Designated as safety issue: Yes ]
  • Rates of injecting and needle sharing
  • adherence to study drug/placebo
  • HIV viral load and CD4 counts
  • antiretroviral resistance
  • genetic characteristics of infecting
  • the number of unprotected sexual acts over the course of the trial
  • number of reported sexual partners over the course of the trial
  • proportional use of condoms during sexual intercourse
Not Provided
Not Provided
 
Bangkok Tenofovir Study
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
Device: Tenofovir
  • Active Comparator: Tenofovir
    Tenofovir
    Intervention: Device: Tenofovir
  • Placebo Comparator: Placebo
    Intervention: Device: Tenofovir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2413
June 2013
July 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00119106
CDC-NCHSTP-4370
Yes
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Ministry of Health, Thailand
  • Bangkok Metropolitan Administration Medical College and Vajira Hospital
Principal Investigator: Kachit Choopanya, MD Bangkok Tenofovir Study Group
Study Director: Michael T Martin, MD, MPH Centers for Disease Control and Prevention
Study Director: Lynn Paxton, MD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP