Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatitis C Heroin Dependence

Keywords

heroin addiction

Outcome Measures

Primary Outcomes (1)

Safety assessments

Secondary Outcomes (2)

Effectiveness of medication
Compliance

Study Arms (1)

pegInterferon

EXPERIMENTAL

Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone

Drug: Buprenorphine/naloxoneDrug: pegInterferon

Interventions

Buprenorphine/naloxoneDrug

Human subjects HIV, HCV

pegInterferon

pegInterferonDrug

intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Buprenorphine/naloxone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Active heroin or other illicit opioid use
Active hepatitis C

Sponsors & Collaborators

Organization to Achieve Solutions in Substance Abuse (OASIS)
Othercollaborator
National Institute on Drug Abuse (NIDA)
NIHlead

Study Sites (1)

O.A.S.I.S.

Oakland, California, 94612, United States

MeSH Terms

Conditions

Hepatitis CHeroin Dependence

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesOpioid-Related Disorders

Study Officials

Diana L Sylvestre, M.D.
Organization to Achieve Solutions in Substance Abuse (OASIS)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Expanded Access: Yes

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2004

Actual (reported)

Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

pegInterferon

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

pegInterferon

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations