Bangkok Tenofovir Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Centers for Disease Control and Prevention.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Device: Tenofovir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2413
Study Start Date: June 2005
Estimated Study Completion Date: June 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir
Tenofovir
Device: Tenofovir
Placebo Comparator: Placebo Device: Tenofovir

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119106

Locations
Thailand
Thailand Ministry of Public Health - U.S. CDC Collaboration
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Ministry of Health, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
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
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00119106     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4370
Study First Received: July 8, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
HIV
Prevention
Tenofovir
HIV Seronegativity

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2014