NCT01550341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

February 23, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

June 21, 2011

Results QC Date

August 17, 2017

Last Update Submit

April 27, 2020

Conditions

Human Immunodeficiency VirusAcquired Immunodeficiency SyndromeOpiate AddictionDrug Dependence

Keywords

HIVAIDSOpiate AddictionDrug DependenceBuprenorphine

Outcome Measures

Primary Outcomes (12)

  • CD4 Count Absolute

    CD4 Count Absolute

    Baseline

  • CD4 Count Absolute

    CD4 Count Absolute

    6 Months

  • CD4 Count Absolute

    CD4 Count

    12 Months

  • CD4 Percent

    CD4 Percent

    Baseline

  • CD4 Percent

    CD4 Percent

    6 Months

  • CD4 Percent

    CD4 Percent

    12 Months

  • Viral Load

    Viral Load

    Baseline

  • Viral Load

    Viral Load

    6 Months

  • Viral Load

    Viral Load

    12 Months

  • Log Viral Load

    Log Viral Load

    Baseline

  • Log Viral Load

    Log Viral Load

    6 Months

  • Log Viral Load

    Log Viral Load

    12 Months

Secondary Outcomes (2)

  • Improved Opioid Treatment Outcomes

    baseline, 3 months, 9 months, 12 months

  • Improved Criminal Justice Outcomes

    baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52

Study Arms (2)

Buprenorphine

ACTIVE COMPARATOR
Drug: Buprenorphine/naloxone

Placebo

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

Buprenorphine/naloxoneDRUG

2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Also known as: Suboxone
Buprenorphine
Placebo Oral TabletDRUG

2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeOpioid-Related DisordersSubstance-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNarcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Frederick Altice, Principal Investigator
Organization
Yale University
frederick.altice@yale.edu
203-737-2883

Study Officials

  • Frederick Altice, MD

    Yale University School of Medicine/AIDS Program

    PRINCIPAL INVESTIGATOR

  • Faye Taxman, PhD

    George Mason University

    PRINCIPAL INVESTIGATOR

  • William Lawson, MD

    Howard University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

March 12, 2012

Study Start

February 23, 2012

Primary Completion

November 30, 2015

Study Completion

November 30, 2016

Last Updated

May 6, 2020

Results First Posted

May 6, 2020

Record last verified: 2020-04

Locations

US(1)