Phase 4
Completed N=20
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Source: ClinicalTrials.gov NCT01285050 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Nov 2016
Primary outcomePrimary: HCV RNA — 0.65; 0.81 log IU/ml
◆ Published Evidence
Established
42citations · ~5 / year
Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs.
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).
Linked Publications (2)
-
Presence of Human Hepegivirus-1 in a Cohort of People Who Inject Drugs.
-
Intracellular HIV-1 RNA and CD4+ T-cell activation in patients starting antiretrovirals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HCV RNA |
0.65; 0.81 | — |
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
Data sourced from ClinicalTrials.gov (NCT01285050) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.