Trial · NCT00270257
Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
NCT00270257, Phase 3, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-12-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users. Trials, record NCT00270257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00270257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
- NCT number
- NCT00270257
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,251 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections, Opioid-Related Disorders
- Interventions
- Buprenorphine/Naloxone
- First posted
- 2005-12-26
- Last updated
- 2021-11-05
- Results first posted
- 2016-12-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | For visits up to week 104 | The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect. |
| Secondary | Number of Participants With Urinalysis Results Positive for Opiates | Measured through Week 104 | Urine drug screen were assessed monthly and semiannually. |
| Secondary | Self-report of Continued Injection Opiate Use in the Last 30 Days | Measured through Week 104 | All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits. |
| Secondary | Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Measured through Week 104 | |
| Secondary | Self-reported Number of Injections in the Last Month | Measured through Week 104 | |
| Secondary | Incident Hepatitis C Infections for Thailand and China | Measured through week 156 in Thailand and 104 weeks in China | HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later. If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint). Analysis was done separately for both countries |
| Secondary | Incident Hepatitis B Infections | Measured through week 52 | Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | For visits up to week 104 | Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012. | participants | NUMBER |
| SECONDARY | Number of Participants With Urinalysis Results Positive for Opiates | Measured through Week 104 | Number of participants presented here applies to visit 104 for whom data available. | participants | NUMBER |
| SECONDARY | Self-report of Continued Injection Opiate Use in the Last 30 Days | Measured through Week 104 | Number of participants presented here applies to whom data available at week 104. | participants | NUMBER |
| SECONDARY | Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Measured through Week 104 | Number of participants presented here applies to whom data available at week 104. | participants | NUMBER |
| SECONDARY | Self-reported Number of Injections in the Last Month | Measured through Week 104 | Number of participants presented here applies to whom data available at week 104. | injections | MEDIAN |
| SECONDARY | Incident Hepatitis C Infections for Thailand and China | Measured through week 156 in Thailand and 104 weeks in China | Baseline HCV antibody negative participants. | participants with HCV antibody | NUMBER |
| SECONDARY | Incident Hepatitis B Infections | Measured through week 52 | participants with HBsAg | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | Long Term Medication Assisted Treatment (LT-MAT) | # of HIV infections | 2 | participants | |
| Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | Short Term Medication Assisted Treatment (ST-MAT) | # of HIV infections | 5 | participants | |
| Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | Long Term Medication Assisted Treatment (LT-MAT) | # of Deaths | 8 | participants | |
| Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | Short Term Medication Assisted Treatment (ST-MAT) | # of Deaths | 9 | participants | |
| Number of Participants With Urinalysis Results Positive for Opiates | Long Term Medication Assisted Treatment (LT-MAT) | 138 | participants | ||
| Number of Participants With Urinalysis Results Positive for Opiates | Short Term Medication Assisted Treatment (ST-MAT) | 141 | participants | ||
| Self-report of Continued Injection Opiate Use in the Last 30 Days | Long Term Medication Assisted Treatment (LT-MAT) | 102 | participants | ||
| Self-report of Continued Injection Opiate Use in the Last 30 Days | Short Term Medication Assisted Treatment (ST-MAT) | 107 | participants | ||
| Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Long Term Medication Assisted Treatment (LT-MAT) | 23 | participants | ||
| Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Short Term Medication Assisted Treatment (ST-MAT) | 28 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Long Term Medication Assisted Treatment (LT-MAT) | 623 | |
| Overall Study | STARTED | Short Term Medication Assisted Treatment (ST-MAT) | 628 | |
| Overall Study | Week 8 | Long Term Medication Assisted Treatment (LT-MAT) | 510 | |
| Overall Study | Week 8 | Short Term Medication Assisted Treatment (ST-MAT) | 443 | |
| Overall Study | Week 26 | Long Term Medication Assisted Treatment (LT-MAT) | 460 | |
| Overall Study | Week 26 | Short Term Medication Assisted Treatment (ST-MAT) | 440 | |
| Overall Study | Week 52 | Long Term Medication Assisted Treatment (LT-MAT) | 362 | |
| Overall Study | Week 52 | Short Term Medication Assisted Treatment (ST-MAT) | 340 | |
| Overall Study | Week 78 | Long Term Medication Assisted Treatment (LT-MAT) | 283 | |
| Overall Study | Week 78 | Short Term Medication Assisted Treatment (ST-MAT) | 285 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | chest Injury | Injury, poisoning and procedural complications | Long Term Medication Assisted Treatment (LT-MAT) | 0 | 623 | 0 |
| other | chest Injury | Injury, poisoning and procedural complications | Short Term Medication Assisted Treatment (ST-MAT) | 1 | 628 | 1 |
| serious | Aortic valve incompetence | Cardiac disorders | Long Term Medication Assisted Treatment (LT-MAT) | 0 | 623 | 0 |
| serious | Aortic valve incompetence | Cardiac disorders | Short Term Medication Assisted Treatment (ST-MAT) | 1 | 628 | 1 |
| serious | Cardiac failure | Cardiac disorders | Long Term Medication Assisted Treatment (LT-MAT) | 0 | 623 | 0 |
| serious | Cardiac failure | Cardiac disorders | Short Term Medication Assisted Treatment (ST-MAT) | 1 | 628 | 1 |
| serious | Cardiopulmonary failure | Cardiac disorders | Long Term Medication Assisted Treatment (LT-MAT) | 1 | 623 | 1 |
| serious | Cardiopulmonary failure | Cardiac disorders | Short Term Medication Assisted Treatment (ST-MAT) | 0 | 628 | 0 |
| serious | Myocardial infarction | Cardiac disorders | Long Term Medication Assisted Treatment (LT-MAT) | 1 | 623 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Short Term Medication Assisted Treatment (ST-MAT) | 0 | 628 | 0 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Long Term Medication Assisted Treatment (LT-MAT) | ||
| Total, all-cause mortality | Short Term Medication Assisted Treatment (ST-MAT) | ||
| Total, other adverse events | Long Term Medication Assisted Treatment (LT-MAT) | 0 | 623 |
| Total, other adverse events | Short Term Medication Assisted Treatment (ST-MAT) | 1 | 628 |
| Total, serious adverse events | Long Term Medication Assisted Treatment (LT-MAT) | 38 | 623 |
| Total, serious adverse events | Short Term Medication Assisted Treatment (ST-MAT) | 42 | 628 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Long Term Medication Assisted Treatment (LT-MAT) vs Short Term Medication Assisted Treatment (ST-MAT): Self-report of Continued Injection Opiate Use in the Last 30 Days | Trial comparisons |
Long Term Medication Assisted Treatment (LT-MAT) vs Short Term Medication Assisted Treatment (ST-MAT): Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Trial comparisons |
| Long Term Medication Assisted Treatment (LT-MAT) vs Short Term Medication Assisted Treatment (ST-MAT): Number of Participants With Urinalysis Results Positive for Opiates | Trial comparisons |
| Long Term Medication Assisted Treatment (LT-MAT) vs Short Term Medication Assisted Treatment (ST-MAT): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00270257
GET https://conductscience.org/api/trials/v1/NCT00270257/events?page=2