Acquired Immunodeficiency Syndrome, Drug Dependence, Human Immunodeficiency Virus, Opiate Addiction
Conditions
Keywords
HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine
Brief summary
The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.
Detailed description
Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months. STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.
Interventions
DRUGBuprenorphine/naloxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
DRUGPlacebo Oral Tablet
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Sponsors
George Mason University
Howard University
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV+ * Age ≥18 yrs * Meets DSM-IV criteria for opioid dependence * Has medical entitlements in DC * Able to provide informed consent * Able to communicate in English or Spanish
Exclusion criteria
* Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition * Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine * AST and ALT \>5x the upper limit of normal (AST≥175, ALT≥195) * Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.) * Breastfeeding or unwilling to stop breastfeeding * Subject is part of another pharmacological research study * Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction) * Suicidal ideation * Hypersensitivity to buprenorphine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4 Count Absolute | Baseline | CD4 Count Absolute |
| CD4 Percent | Baseline | CD4 Percent |
| Viral Load | Baseline | Viral Load |
| Log Viral Load | Baseline | Log Viral Load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Opioid Treatment Outcomes | baseline, 3 months, 9 months, 12 months | Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year. |
| Improved Criminal Justice Outcomes | baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 | Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buprenorphine Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. | 32 |
| Placebo Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. | 18 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo | Buprenorphine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 32 Participants | 49 Participants |
| Age, Continuous | 55.59 Years STANDARD_DEVIATION 5.26 | 51.29 Years STANDARD_DEVIATION 6.54 | 52.81 Years STANDARD_DEVIATION 6.41 |
| Region of Enrollment United States | 18 Participants | 32 Participants | 50 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 23 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 18 |
| other Total, other adverse events | 0 / 32 | 0 / 18 |
| serious Total, serious adverse events | 0 / 32 | 0 / 18 |
Outcome results
Primary
CD4 Count Absolute
CD4 Count
Time frame: 12 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Count Absolute | 490.25 cells/uL | Standard Deviation 298.65 |
| Placebo | CD4 Count Absolute | 492.33 cells/uL | Standard Deviation 260.43 |
Primary
CD4 Count Absolute
CD4 Count Absolute
Time frame: 6 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Count Absolute | 455.52 cells/uL | Standard Deviation 289.74 |
| Placebo | CD4 Count Absolute | 551.23 cells/uL | Standard Deviation 82.12 |
Primary
CD4 Count Absolute
CD4 Count Absolute
Time frame: Baseline
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Count Absolute | 486.15 cells/uL | Standard Deviation 308.34 |
| Placebo | CD4 Count Absolute | 403.92 cells/uL | Standard Deviation 233.89 |
Primary
CD4 Percent
CD4 Percent
Time frame: 6 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Percent | 21.33 CD4 Percent | Standard Deviation 1.88 |
| Placebo | CD4 Percent | 28.56 CD4 Percent | Standard Deviation 12.1 |
Primary
CD4 Percent
CD4 Percent
Time frame: Baseline
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Percent | 23.36 CD4 Percent | Standard Deviation 8.56 |
| Placebo | CD4 Percent | 25.7 CD4 Percent | Standard Deviation 12.38 |
Primary
CD4 Percent
CD4 Percent
Time frame: 12 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | CD4 Percent | 22.14 CD4 Percent | Standard Deviation 9.6 |
| Placebo | CD4 Percent | 27.95 CD4 Percent | Standard Deviation 12.14 |
Primary
Log Viral Load
Log Viral Load
Time frame: Baseline
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Log Viral Load | 2.12 log(IU/mL) | Standard Deviation 1.02 |
| Placebo | Log Viral Load | 2.00 log(IU/mL) | Standard Deviation 0.97 |
Primary
Log Viral Load
Log Viral Load
Time frame: 12 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Log Viral Load | 2.40 log(IU/mL) | Standard Deviation 1.33 |
| Placebo | Log Viral Load | 1.84 log(IU/mL) | Standard Deviation 1.44 |
Primary
Log Viral Load
Log Viral Load
Time frame: 6 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Log Viral Load | 2.22 log(IU/mL) | Standard Deviation 1.35 |
| Placebo | Log Viral Load | 1.79 log(IU/mL) | Standard Deviation 1.11 |
Primary
Viral Load
Viral Load
Time frame: 6 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Viral Load | 9269.04 IU/mL | Standard Deviation 4778.9 |
| Placebo | Viral Load | 7891.08 IU/mL | Standard Deviation 26598.95 |
Primary
Viral Load
Viral Load
Time frame: Baseline
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Viral Load | 1465.00 IU/mL | Standard Deviation 551.17 |
| Placebo | Viral Load | 896.50 IU/mL | Standard Deviation 1569.7 |
Primary
Viral Load
Viral Load
Time frame: 12 Months
Population: Participants with complete lab results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buprenorphine | Viral Load | 8122.10 IU/mL | Standard Deviation 18268.77 |
| Placebo | Viral Load | 19425.71 IU/mL | Standard Deviation 51342.69 |
Secondary
Improved Criminal Justice Outcomes
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Time frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52
Population: These data were never collected and summarized due to the change in study design (see study description).
Secondary
Improved Opioid Treatment Outcomes
Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.
Time frame: baseline, 3 months, 9 months, 12 months
Population: This outcome was not collected and analyzed due to the change in study design (see study description).