Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Anti-Retroviral Agents; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Interferon-alpha; Interferons; Raltegravir Potassium; Tenofovir

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