Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
NCT ID: NCT01285050
Last Updated: 2016-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2011-01-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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)
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.
raltegravir
raltegravir is an HIV medication given 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Interventions
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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.
raltegravir
raltegravir is an HIV medication given 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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David Thomas
Chief, Infectious Diseases
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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References
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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.
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.
Other Identifiers
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NA00040361
Identifier Type: -
Identifier Source: org_study_id