Clinical trial NCT01285050: Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Official title: Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Hepatitis C
Keywords: 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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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 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

Primary outcomes:
measure: HCV RNA
timeFrame: 48 hours after interferon administration
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References:
citation: 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.
citation: 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.