Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119106
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2005-07-08
Brief Title:
Bangkok Tenofovir Study an HIV Pre-exposure Prophylaxis Trial Bangkok Thailand
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok Thailand
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
This is a phase IIIII 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 11 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 2400 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 hisher study medication and clinic staff will initial the participants 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
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 2400 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 hisher study medication and clinic staff will initial the participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None