Trial Outcomes & Findings for Alcohol Pharmacotherapy for HIV+ Prisoners (NCT NCT01077310)
NCT ID: NCT01077310
Last Updated: 2017-05-30
Results Overview
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline to month 6 post release
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Extended-release Naltrexone
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
33
|
|
Overall Study
COMPLETED
|
67
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol Pharmacotherapy for HIV+ Prisoners
Baseline characteristics by cohort
| Measure |
Extended-release Naltrexone
n=67 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=33 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (non Hispanic)
|
46 participants
n=5 Participants
|
19 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (non Hispanic)
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
33 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Alcohol use severity by AUDIT
Abstinent or Low Risk Drinking
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Alcohol use severity by AUDIT
Hazardous Drinking
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Alcohol use severity by AUDIT
Harmful Drinking
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Alcohol use severity by AUDIT
Possible Dependence
|
60 participants
n=5 Participants
|
27 participants
n=7 Participants
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 6 post releasePopulation: Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
Outcome measures
| Measure |
Intramuscular Naltrexone
n=67 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=33 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
Extended-release Naltrexone, Received 4-6 Injections
|
Placebo, Received 4-6 Injections
|
|---|---|---|---|---|
|
Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
|
54 percent of participants
|
42 percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post releaseSelf reported time to first heavy drinking day after release from incarceration, up to 6 months
Outcome measures
| Measure |
Intramuscular Naltrexone
n=67 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=33 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
Extended-release Naltrexone, Received 4-6 Injections
|
Placebo, Received 4-6 Injections
|
|---|---|---|---|---|
|
Alcohol Treatment Outcome: Time to Alcohol Relapse
Age 20-29
|
24.1 days
Standard Deviation 25.8
|
9.5 days
Standard Deviation 10.6
|
—
|
—
|
|
Alcohol Treatment Outcome: Time to Alcohol Relapse
Age 30-39
|
78.9 days
Standard Deviation 49.5
|
73.9 days
Standard Deviation 90.1
|
—
|
—
|
|
Alcohol Treatment Outcome: Time to Alcohol Relapse
Agge 40-49
|
98.8 days
Standard Deviation 70.4
|
85.0 days
Standard Deviation 66.9
|
—
|
—
|
|
Alcohol Treatment Outcome: Time to Alcohol Relapse
Age 50+
|
60.3 days
Standard Deviation 74.1
|
64.1 days
Standard Deviation 66.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks prior to release from prison (baseline) to 6 months post releaseThe mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day
Outcome measures
| Measure |
Intramuscular Naltrexone
n=40 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=19 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
Extended-release Naltrexone, Received 4-6 Injections
n=27 Participants
|
Placebo, Received 4-6 Injections
n=14 Participants
|
|---|---|---|---|---|
|
Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day
|
-16.6 standard units of alcohol
Standard Deviation 22.2
|
-29.6 standard units of alcohol
Standard Deviation 27.5
|
-17.4 standard units of alcohol
Standard Deviation 25.0
|
-14.9 standard units of alcohol
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-releasechange in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.
Outcome measures
| Measure |
Intramuscular Naltrexone
n=40 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=19 Participants
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
Extended-release Naltrexone, Received 4-6 Injections
n=27 Participants
|
Placebo, Received 4-6 Injections
n=14 Participants
|
|---|---|---|---|---|
|
Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days
|
-38.3 percent of heavy drinking days
Standard Deviation 44.8
|
-51.3 percent of heavy drinking days
Standard Deviation 41.1
|
-63.6 percent of heavy drinking days
Standard Deviation 38.8
|
-54.9 percent of heavy drinking days
Standard Deviation 46.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and every 3 months for 1 yearPopulation: These data were not able to be collected for analysis.
Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.
Outcome measures
Outcome data not reported
Adverse Events
Extended-release Naltrexone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended-release Naltrexone
n=67 participants at risk
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
|
Placebo
n=33 participants at risk
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.4%
9/67 • Number of events 22 • full study duration, up to 48 weeks post release
|
6.1%
2/33 • Number of events 4 • full study duration, up to 48 weeks post release
|
|
General disorders
headache
|
7.5%
5/67 • Number of events 14 • full study duration, up to 48 weeks post release
|
6.1%
2/33 • Number of events 3 • full study duration, up to 48 weeks post release
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place