Trial Outcomes & Findings for Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up (NCT NCT03275350)

NCT ID: NCT03275350

Last Updated: 2022-04-27

Results Overview

HIV-1 RNA \<200 copies/ml

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 114 participants
• Primary outcome timeframe: 12 weeks and 24 weeks
• Results posted on: 2022-04-27

Participant Flow

Participant milestones

Measure	Extended-release Naltrexone (XR-NTX) Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Overall Study STARTED	55	59
Overall Study COMPLETED	47	51
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Measure	Extended-release Naltrexone (XR-NTX) Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Overall Study Lost to Follow-up	4	6
Overall Study Death	2	1
Overall Study Physician Decision	1	0
Overall Study Incarcerated	1	1

Baseline Characteristics

Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

Baseline characteristics by cohort

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic	Total n=114 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 10.8 • n=5 Participants	46 years STANDARD_DEVIATION 11.5 • n=7 Participants	47 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
HIV Viral Load	4.0 log10 copies/mL STANDARD_DEVIATION 0.9 • n=5 Participants	4.0 log10 copies/mL STANDARD_DEVIATION 1.1 • n=7 Participants	4.0 log10 copies/mL STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks and 24 weeks

Population: Non-inferiority analyses of HIV viral suppression by treatment arm Intent to Treat Group Missing imputed as unsuppressed

HIV-1 RNA <200 copies/ml

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed 12 Weeks	23 Participants	21 Participants
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed 24 Weeks	29 Participants	29 Participants

PRIMARY outcome

Timeframe: 12 weeks and 24 weeks

Population: Non-inferiority analyses of HIV viral suppression by treatment arm Complete case: Includes 81 participants with non-missing viral load data at 12 and 24 weeks

HIV-1 RNA <200 copies/ml

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=39 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=42 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With HIV Viral Suppression, Complete Case 12 Weeks	23 Participants	19 Participants
Number of Participants With HIV Viral Suppression, Complete Case 24 Weeks	26 Participants	26 Participants

PRIMARY outcome

Timeframe: 12 weeks and 24 weeks

Population: Non-inferiority analyses of HIV viral suppression by treatment arm Missing as unsuppressed Per-protocol population includes 69 participants who received at least one dose of their assigned study medication.

HIV-1 RNA <200 copies/ml

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=26 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=43 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With HIV Viral Suppression, Per-protocol 12 weeks	11 Participants	16 Participants
Number of Participants With HIV Viral Suppression, Per-protocol 24 weeks	15 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Absolute value of participant VACS Index at baseline and 24 weeks

Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Veterans Aging Cohort Study (VACS) Index Baseline	65.1 score on a scale Standard Deviation 18.1	68.4 score on a scale Standard Deviation 24.7
Veterans Aging Cohort Study (VACS) Index 24 Weeks	54.4 score on a scale Standard Deviation 20.7	63.5 score on a scale Standard Deviation 25.4

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Cluster of Differentiation 4

Absolute value of CD4 count at baseline and 24 weeks.

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
CD4 Count Baseline	380.7 cells/mm3 Standard Deviation 248.2	439.8 cells/mm3 Standard Deviation 336.6
CD4 Count 24 Weeks	459.1 cells/mm3 Standard Deviation 249.1	505.1 cells/mm3 Standard Deviation 349.1

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Number analyzed at 24 weeks lower than baseline due to study retention and availability of data.

Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Engagement in HIV Care: Antiretroviral Therapy Prescribed Baseline	37 Participants	46 Participants
Engagement in HIV Care: Antiretroviral Therapy Prescribed 24 Weeks	45 Participants	43 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.

Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=45 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=45 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence	16 Participants	13 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.

At least 1 HIV care visit in past 12 weeks

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=52 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=58 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks	31 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Those reporting no sex are excluded.

Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=27 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=30 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants Who Had Unprotected Sex in Past 30 Days Baseline	15 Participants	16 Participants
Number of Participants Who Had Unprotected Sex in Past 30 Days 24 Weeks	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Two or more sex partners during past month, those reporting no sex partners are excluded

Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=25 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=26 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With Multiple Sex Partners in Past 30 Days Baseline	10 Participants	6 Participants
Number of Participants With Multiple Sex Partners in Past 30 Days 24 Weeks	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.

Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Engagement in HIV Care: Quality of Life Baseline	58 score on a scale Standard Deviation 19.1	64.3 score on a scale Standard Deviation 17.6
Engagement in HIV Care: Quality of Life 24 Weeks	67.9 score on a scale Standard Deviation 21.2	71.2 score on a scale Standard Deviation 19.1

SECONDARY outcome

Timeframe: Between baseline and 24 weeks

Population: Per-protocol population includes participants who received at least one dose of their assigned study medication.

Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Average Number of Self-Reported Days of Opioid Use in Last 30 Days Intent-to-treat	11.73 days Interval 0.0 to 30.0	14.81 days Interval 0.0 to 30.0
Average Number of Self-Reported Days of Opioid Use in Last 30 Days Per-protocol	6.02 days Interval 0.0 to 30.0	13.58 days Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Per-protocol population includes participants who received at least one dose of their assigned study medication.

Number and percent of participants with UDS positive for opioids at 24 weeks.

Outcome measures

Measure	Extended-release Naltrexone (XR-NTX) n=55 Participants Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 Participants Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants Who Test Positive for Opioids at 24 Weeks Intent-to-treat	34 Participants	40 Participants
Number of Participants Who Test Positive for Opioids at 24 Weeks Per-protocol	10 Participants	30 Participants

Adverse Events

Extended-release Naltrexone (XR-NTX)

Serious events: 5 serious events

Other events: 11 other events

Deaths: 2 deaths

Treatment as Usual (TAU)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	Extended-release Naltrexone (XR-NTX) n=55 participants at risk Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 participants at risk Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Infections and infestations Infections	3.6% 2/55 • Number of events 2 • 24 weeks	5.1% 3/59 • Number of events 3 • 24 weeks
Psychiatric disorders Psychiatric disorders	3.6% 2/55 • Number of events 2 • 24 weeks	1.7% 1/59 • Number of events 1 • 24 weeks
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.00% 0/55 • 24 weeks	3.4% 2/59 • Number of events 2 • 24 weeks
Vascular disorders Vascular disorders	1.8% 1/55 • Number of events 1 • 24 weeks	0.00% 0/59 • 24 weeks
Respiratory, thoracic and mediastinal disorders Respiratory disorders	1.8% 1/55 • Number of events 1 • 24 weeks	0.00% 0/59 • 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/55 • 24 weeks	1.7% 1/59 • Number of events 1 • 24 weeks

Other adverse events

Measure	Extended-release Naltrexone (XR-NTX) n=55 participants at risk Extended-release naltrexone Naltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone	Treatment as Usual (TAU) n=59 participants at risk Treatment as usual Treatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic
Infections and infestations Infections	3.6% 2/55 • Number of events 2 • 24 weeks	8.5% 5/59 • Number of events 5 • 24 weeks
Injury, poisoning and procedural complications Injury	1.8% 1/55 • Number of events 1 • 24 weeks	3.4% 2/59 • Number of events 2 • 24 weeks
Gastrointestinal disorders Gastrointestinal disorders	5.5% 3/55 • Number of events 3 • 24 weeks	0.00% 0/59 • 24 weeks
Respiratory, thoracic and mediastinal disorders Respiratory disorders	3.6% 2/55 • Number of events 2 • 24 weeks	1.7% 1/59 • Number of events 1 • 24 weeks
Psychiatric disorders Psychiatric disorders	3.6% 2/55 • Number of events 2 • 24 weeks	1.7% 1/59 • Number of events 1 • 24 weeks
Nervous system disorders Nervous system disorders	3.6% 2/55 • Number of events 2 • 24 weeks	0.00% 0/59 • 24 weeks

Additional Information

Dr. Todd Korthuis

Oregon Health & Science University

Phone: 503-494-8044

Email: korthuis@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place