HIV Infection, Hepatitis C
Conditions
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
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.
Interventions
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.
DRUGraltegravir
raltegravir is an HIV medication given 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre Post ART HCV and HIV viral load pre and post antiretroviral therapy
Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.
raltegravir: HIV medication, 400 mg twice daily by mouth
Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pre Post ART |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| HCV infected | 20 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
HCV RNA
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.
Time frame: 48 hours after interferon administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre ART HCV RNA Decline | HCV RNA | 0.65 log IU/ml |
| Post ART HCV Decline | HCV RNA | 0.81 log IU/ml |