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Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01285050
First received: January 26, 2011
Last updated: October 6, 2016
Last verified: October 2016
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Purpose
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: Antiretroviral therapy (ART) Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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:
Further study details as provided by David Thomas, Johns Hopkins University:
Primary Outcome Measures:
- HCV RNA [ Time Frame: 48 hours after interferon administration ]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.
| Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
pre post ART
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)
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.
Drug: raltegravir
raltegravir is an HIV medication given 400 mg twice daily by mouth
Other Name: Isentress
Drug: Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Other Name: Truvada
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01285050
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285050
Locations
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
More Information
| Responsible Party: | David Thomas, Chief, Infectious Diseases, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01285050 History of Changes |
| Other Study ID Numbers: |
NA00040361 R01DA013806 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 26, 2011 |
| Results First Received: | August 15, 2016 |
| Last Updated: | October 6, 2016 |
Keywords provided by David Thomas, 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:
|
Hepatitis Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Interferons Tenofovir Interferon-alpha Raltegravir Potassium Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antineoplastic Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on July 25, 2017