Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
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ClinicalTrials.gov Identifier: NCT01285050 |
Recruitment Status
:
Completed
First Posted
: January 27, 2011
Results First Posted
: November 29, 2016
Last Update Posted
: November 29, 2016
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection Hepatitis C | Drug: Antiretroviral therapy (ART) Drug: raltegravir Drug: Emtricitabine and tenofovir disoproxil fumarate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |
Arm | Intervention/treatment |
---|---|
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)
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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
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- 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.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285050
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ) |
First Posted: | January 27, 2011 Key Record Dates |
Results First Posted: | November 29, 2016 |
Last Update Posted: | November 29, 2016 |
Last Verified: | October 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 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 Immunologic Factors |