NCT01285050

Brief Summary

The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

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

Study Start

First participant enrolled

January 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

January 26, 2011

Results QC Date

August 15, 2016

Last Update Submit

October 6, 2016

Conditions

HIV InfectionHepatitis C

Keywords

HIVHuman immunodeficiency virusAcquired Immune Deficiency Syndrome VirusAIDS VirusImmunodeficiency Virus, HumanVirus, Human ImmunodeficiencyHepatitis CHepatitis C, chronicHepatitis C virusHepatitis C antibodiesHepatitis C antigens

Outcome Measures

Primary Outcomes (1)

  • HCV RNA

    HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.

    48 hours after interferon administration

Study Arms (1)

pre post ART

OTHER

HCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART)

Drug: Antiretroviral therapy (ART)Drug: raltegravirDrug: Emtricitabine and tenofovir disoproxil fumarate

Interventions

Antiretroviral therapy (ART)DRUG

Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.

pre post ART
raltegravirDRUG

raltegravir is an HIV medication given 400 mg twice daily by mouth

Also known as: Isentress
pre post ART
Emtricitabine and tenofovir disoproxil fumarateDRUG

Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth

Also known as: Truvada
pre post ART

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Human
  • Able to provide written informed consent
  • HIV antibody positive
  • HIV viral load positive
  • HIV treatment naive
  • Hepatitis C antibody positive
  • Hepatitis C viral load positive
  • Hepatitis C treatment naive
  • Approved to take HIV medications for minimum 9 months
  • Willing to use contraception, Life expectancy greater than 2 years

You may not qualify if:

  • Significant opportunistic infections within 12 month
  • Hepatitis B positive
  • Evidence of liver cirrhosis
  • Decompensated liver disease
  • Chronic alcohol abuse
  • Allergy to raltegravir, tenofovir, and/or emtricitabine
  • Active or suspected malignancy
  • Sarcoidosis
  • Active TB
  • Coronary artery disease
  • Uncontrolled seizures
  • Untreated thyroid disease
  • Untreated diabetes
  • Weight greater than 125 kg
  • Severe depression or severe psychiatric disorder
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Kandathil AJ, Breitwieser FP, Sachithanandham J, Robinson M, Mehta SH, Timp W, Salzberg SL, Thomas DL, Balagopal A. Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs. Ann Intern Med. 2017 Jul 4;167(1):1-7. doi: 10.7326/M17-0085. Epub 2017 Jun 6.

    PMID: 28586923DERIVED

  • El-Diwany R, Breitwieser FP, Soliman M, Skaist AM, Srikrishna G, Blankson JN, Ray SC, Wheelan SJ, Thomas DL, Balagopal A. Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals. AIDS. 2017 Jun 19;31(10):1405-1414. doi: 10.1097/QAD.0000000000001480.

    PMID: 28358734DERIVED

MeSH Terms

Conditions

HIV InfectionsHepatitis CAcquired Immunodeficiency SyndromeHepatitis C, Chronic

Interventions

Antiretroviral Therapy, Highly ActiveRaltegravir PotassiumEmtricitabineTenofovirEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesSlow Virus DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeuticsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
David Thomas
Organization
Johns Hopkins University
dthomas@jhmi.edu
410-502-6043

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Infectious Diseases

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 29, 2016

Results First Posted

November 29, 2016

Record last verified: 2016-10

Locations

US(1)