Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
This study is currently recruiting participants.
Verified February 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01285050
First received: January 26, 2011
Last updated: February 13, 2013
Last verified: February 2013
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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).
Condition | Intervention | Phase |
---|---|---|
HIV Infection Hepatitis C |
Drug: Anti-HIV Agents Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate |
Phase 4 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
Official Title: | Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Interferon
Interferon alfa-2a
Emtricitabine
Tenofovir
Tenofovir Disoproxil Fumarate
Raltegravir
Truvada
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- HCV RNA [ Time Frame: 48 hours after interferon administration ] [ Designated as safety issue: No ]HCV RNA 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.
Secondary Outcome Measures:
- HIV RNA [ Time Frame: Pre and post administration of HIV meds ] [ Designated as safety issue: No ]HIV quantatative viral load
- ISG [ Time Frame: Pre and post interferon administration ] [ Designated as safety issue: No ]Interferon stimulated genes as assessed in liver tissue and PBMC.
Estimated Enrollment: | 40 |
Study Start Date: | January 2011 |
Estimated Study Completion Date: | July 2015 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Anti-HIV Agents
Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
Other Name: PegIntron
Drug: raltegravir
HIV medication, 400 mg twice daily by mouth
Other Name: Isentress
Drug: Emtricitabine and tenofovir disoproxil fumarate
HIV medication, combination pill, once per day by mouth
Other Name: Truvada
We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.
![](https://webarchive.library.unt.edu/web/20130305095822im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Ongoing alcohol or illicit drug use
- Pregnant, nursing, pr planning to become pregnant
- Allergy to interferon
![](https://webarchive.library.unt.edu/web/20130305095822im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285050
Contacts
Contact: Rosie Silva | 410-502-7134 | rsilva6@jhmi.edu |
Locations
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Rosie Silva 410-502-7134 rsilva6@jhmi.edu | |
Principal Investigator: David L Thomas, MD, MPH |
Sponsors and Collaborators
Johns Hopkins University
![](https://webarchive.library.unt.edu/web/20130305095822im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | David Thomas, Chief, Infectious Diseases, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01285050 History of Changes |
Other Study ID Numbers: | NA00040361, R01DA013806 |
Study First Received: | January 26, 2011 |
Last Updated: | February 13, 2013 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
HIV Human immunodeficiency virus Acquired Immune Deficiency Syndrome Virus AIDS Virus Immunodeficiency Virus, Human Virus, Human Immunodeficiency |
Hepatitis C Hepatitis C, chronic Hepatitis C virus Hepatitis C antibodies Hepatitis C antigens |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Tenofovir Tenofovir disoproxil Emtricitabine Anti-HIV Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2013