Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270257
Status:
TERMINATED
Last Update Posted:
2021-11-05
First Post:
2005-12-22
Brief Title:
Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drug abuse and HIVAIDS are serious global health problems Injection drug use is currently the major mode of transmission of HIV in many countries The purpose of this study is to determine the effectiveness of drug and risk reduction counseling combined with either substitution drug treatment with buprenorphinenaloxone BUPNX or short-term detoxification with BUPNX in preventing HIV transmission among injection drug users Participants will be recruited for this study in China and Thailand
Detailed Description:
Effective HIV prevention among injection drug users IDUs requires educating the at-risk population about HIV transmission and risky behavior and providing the means for behavior change Current treatment for opiate dependence focuses on reducing the frequency of drug use BUPNX is a combination pill currently used to treat opiate-dependent individuals This trial will evaluate the effectiveness of two therapies in preventing HIV transmission among IDUs Drug and risk reduction counseling combined with either long term medication assisted treatment LT-MAT with BUPNX or short term medication assisted treatment ST-MAT with BUPNX will be compared in preventing the transmission of HIV among opiate-dependent individuals
This study will last 45 years Participants in this study will be randomly assigned to one of two treatment arms Group 1 will receive LT-MAT with BUPNX Group 2 will receive ST-MAT with BUPNX An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 30 weeks Study visits will occur every week and will include a physical exam and blood and urine collection
The main treatment phase of the study will last 52 weeks Participants in Group 1 will receive BUPNX under the tongue at first daily and then three times a week for 52 weeks Participants assigned to Group 1 will take part in a BUPNX reduction phase which will occur between Weeks 47 and 52 Participants in Group 2 will receive short-term BUPNX dosage and length of treatment will be determined by the investigator Participants assigned to Group 2 will receive BUPNX for a maximum of 18 days detoxification may be repeated at Week 26 if the participant is still injecting opiates After Week 4 of the safety phase and Weeks 26 and 52 of the overall study participants will complete an intervention acceptability assessment
In addition participants in both groups will attend drug and risk reduction counseling weekly After the first 12 weeks participants will return every 4 weeks for 10 more counseling sessions HIV testing hepatitis C testing risk assessment and urine tests for opiates will occur at screening and at Weeks 26 52 78 104 130 and 156 Plasma from blood samples will be stored at each of these visits Hepatitis B testing will occur at Week 26 Participants in China will attend study visits through approximately Week 104 and participants in Thailand will attend study visits through approximately Week 156
Participants in China who have been incarcerated may participate in an optional substudy which is examining the withdrawal effects from BUPNX after incarceration Participants who agree to take part in the substudy will attend one study visit and will complete a questionnaire
This study will last 45 years Participants in this study will be randomly assigned to one of two treatment arms Group 1 will receive LT-MAT with BUPNX Group 2 will receive ST-MAT with BUPNX An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 30 weeks Study visits will occur every week and will include a physical exam and blood and urine collection
The main treatment phase of the study will last 52 weeks Participants in Group 1 will receive BUPNX under the tongue at first daily and then three times a week for 52 weeks Participants assigned to Group 1 will take part in a BUPNX reduction phase which will occur between Weeks 47 and 52 Participants in Group 2 will receive short-term BUPNX dosage and length of treatment will be determined by the investigator Participants assigned to Group 2 will receive BUPNX for a maximum of 18 days detoxification may be repeated at Week 26 if the participant is still injecting opiates After Week 4 of the safety phase and Weeks 26 and 52 of the overall study participants will complete an intervention acceptability assessment
In addition participants in both groups will attend drug and risk reduction counseling weekly After the first 12 weeks participants will return every 4 weeks for 10 more counseling sessions HIV testing hepatitis C testing risk assessment and urine tests for opiates will occur at screening and at Weeks 26 52 78 104 130 and 156 Plasma from blood samples will be stored at each of these visits Hepatitis B testing will occur at Week 26 Participants in China will attend study visits through approximately Week 104 and participants in Thailand will attend study visits through approximately Week 156
Participants in China who have been incarcerated may participate in an optional substudy which is examining the withdrawal effects from BUPNX after incarceration Participants who agree to take part in the substudy will attend one study visit and will complete a 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10144 | REGISTRY | DAIDS ES | None |