NCT01550341: STRIDE

HIV, Buprenorphine, and the Criminal Justice System

Completed NA Results posted Last updated 6 May 2020

What this trial tests

NA trial testing Buprenorphine/naloxone in Human Immunodeficiency Virus in 50 participants. Completed in 30 November 2016.

Timeline

23 February 2012

Primary endpoint
30 November 2015

30 November 2016

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	23 February 2012
Primary completion	30 November 2015
Estimated completion	30 November 2016
Sites	1 location across United States

Drugs / interventions tested

• Buprenorphine/naloxone
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Acquired Immunodeficiency Syndrome — all drugs for Acquired Immunodeficiency Syndrome →
• Opiate Addiction — all drugs for Opiate Addiction →
• Drug Dependence — all drugs for Drug Dependence →

Sponsor

Yale University

Who can join

18 and older, any sex, with Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CD4 Count Absolute Primary · Baseline

CD4 Count Absolute

Group	Value	95% CI
Buprenorphine	486.15	± 308.34
Placebo	403.92	± 233.89

CD4 Count Absolute Primary · 6 Months

CD4 Count Absolute

Group	Value	95% CI
Buprenorphine	455.52	± 289.74
Placebo	551.23	± 82.12

CD4 Count Absolute Primary · 12 Months

CD4 Count

Group	Value	95% CI
Buprenorphine	490.25	± 298.65
Placebo	492.33	± 260.43

CD4 Percent Primary · Baseline

CD4 Percent

Group	Value	95% CI
Buprenorphine	23.36	± 8.56
Placebo	25.7	± 12.38

CD4 Percent Primary · 6 Months

CD4 Percent

Group	Value	95% CI
Buprenorphine	21.33	± 1.88
Placebo	28.56	± 12.1

CD4 Percent Primary · 12 Months

CD4 Percent

Group	Value	95% CI
Buprenorphine	22.14	± 9.6
Placebo	27.95	± 12.14

Viral Load Primary · Baseline

Viral Load

Group	Value	95% CI
Buprenorphine	1465.00	± 551.17
Placebo	896.50	± 1569.7

Viral Load Primary · 6 Months

Viral Load

Group	Value	95% CI
Buprenorphine	9269.04	± 4778.9
Placebo	7891.08	± 26598.95

Viral Load Primary · 12 Months

Viral Load

Group	Value	95% CI
Buprenorphine	8122.10	± 18268.77
Placebo	19425.71	± 51342.69

Log Viral Load Primary · Baseline

Log Viral Load

Group	Value	95% CI
Buprenorphine	2.12	± 1.02
Placebo	2.00	± .97

Log Viral Load Primary · 6 Months

Log Viral Load

Group	Value	95% CI
Buprenorphine	2.22	± 1.35
Placebo	1.79	± 1.11

Log Viral Load Primary · 12 Months

Log Viral Load

Group	Value	95% CI
Buprenorphine	2.40	± 1.33
Placebo	1.84	± 1.44

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brief Report: Reduced Use of Illicit Substances, Even Without Abstinence, Is Associated With Improved Depressive Symptoms Among People Living With HIV.
   Delaney JA, Nance RM, Whitney BM, Altice FL, et al · · 2018 · cited 15× · PMID 30036277 · DOI 10.1097/qai.0000000000001803
2. Housing Experiences among Opioid-Dependent, Criminal Justice-Involved Individuals in Washington, D.C.
   Wooditch A, Mbaba M, Kiss M, Lawson W, et al · · 2018 · cited 3× · PMID 28550643 · DOI 10.1007/s11524-017-0156-z