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Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV (ART and HCV)
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00545558
First received: October 15, 2007
Last updated: August 8, 2014
Last verified: August 2014
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Purpose
The purpose of this study is to measure the effects of anti-HIV drugs on hepatitis C virus (HCV) viral load in people infected with both HCV and HIV.
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis C HIV Infections | Drug: Efavirenz Drug: Emtricitabine/Tenofovir disoproxil fumarate | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Antiretroviral Therapy and the Hepatitis C Virus |
Resource links provided by NLM:
Further study details as provided by Kenneth Sherman, University of Cincinnati:
Primary Outcome Measures:
- Underlying patterns of liver injury and hepatitis C virus (HCV) viral changes after antiretroviral therapy (ART) initiation [ Time Frame: Throughout study ]
| Enrollment: | 18 |
| Study Start Date: | April 2006 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive ART consisting of efavirenz and the co-formulation of emtricitabine and tenofovir disoproxil fumarate. If participants are unable to tolerate the treatment, a different regimen will be prescribed.
|
Drug: Efavirenz
600 mg tablet taken orally daily
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally daily
|
Detailed Description:
Coinfection with HCV and HIV occurs in 20% to 30% of HIV infected people in the United States. Individuals with HCV/HIV coinfection tend to have higher HCV viral loads than individuals with HCV alone. However, current evidence suggests that initiation of effective antiretroviral therapy (ART) may be associated with increases in HCV viral load. The purpose of this study is to evaluate changes in HCV viral load associated with the initiation of ART in HCV/HIV coinfected adults.
All participants will receive ART consisting of efavirenz once daily and the co-formulation of emtricitabine and tenofovir disoproxil fumarate (DF) once daily. If participants are unable to tolerate a different regimen would be prescribed.
There will be at least 21 study visits. During the first week of the study, participants will undergo blood draws for viral kinetic sampling and initiation of study medications. Following the first week, there will be weekly visits for 96 weeks. At screening, participants will undergo vital signs measurements, a physical exam, medical history, blood collection, and liver biopsy. During Week 1, participants will be hospitalized for 24 hours for initiation of ART and viral kinetic sampling. Blood draws for viral kinetic sampling of HCV and HIV will be performed at Hours 0, 2, 4, 6, 9, 12, 18, and 24. Participants will return to the clinic or hospital at Hours 48, 72, 96, and 167 for additional viral kinetic sampling. Blood collection will occur at all visits; physical exams, vital signs measurement, a side effects questionnaire, and urine and semen collection will occur at selected visits.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HCV-infected
- HIV-infected
- Liver biopsy consistent with chronic hepatitis within 1 year of study entry.
- ART-naive or no ART for at least 3 months prior to study entry
Exclusion Criteria:
- Hemoglobin less than 9 g/dl.
- Hepatitis B virus infected or antibody to hepatitis B core antigen, alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune disorder, or other concurrent liver disease
- Decompensated liver disease evidenced by active or history of encephalopathy, ascites, or variceal bleeding; prothrombin time (PT) greater than 3 seconds above normal or international normalized ratio (INR) greater than 1.3 sec; platelet count less than 90,000 K/ul. Participants with cirrhosis will not be excluded.
- Active thyroid disease. Participants on thyroid replacement therapy with normal thyroid-stimulating hormone are not excluded.
- Chronic kidney insufficiency, defined as creatinine clearance of greater than approximately 50 ml/min
- Life-threatening disease processes other than HIV or HCV that could interfere with participation in the study
- Any condition that, in the opinion of the investigator, may interfere with completion of the study regimen. This includes severe psychiatric disorders, or active alcohol or recreational drug abuse
- Use of systemic corticosteroids or immunomodulatory drugs within 1 month prior to study entry
- Current or prior successful interferon treatment
- Pregnancy or breastfeeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00545558
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545558
Locations
| United States, Ohio | |
| General Clinical Research Center (GCRC), OH site | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Virginia | |
| Virginia Commonwealth University, School of Medicine | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
University of Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Principal Investigator: | Kenneth E. Sherman, MD, PhD | Unviersity of Cincinnati |
More Information
Publications:
Ma G, Barrett A, Sherman KE, Shata T, Blackard J. Detection of HIV in Liver Biopsies and Intrahepatic Lymphocytes. 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA February 2008
Sherman KE, Rouster S, Feinberg J, Bini E, Blackard J, Shata T. Hepatic Apoptosis following Initiation of ART in HCV/HIV co-infected Subjects. 16th Conference on Retroviruses and Opportunistic Infections, Montreal, Canada February 2009
Blackard J, Ma G, Rouster S, Martin C, Shata T, Sherman K. Baseline hepatitis C virus variability does not predict flares in HIV/HCV co-infected persons initiating antiretroviral therapy. 5th International Workshop on HIV and Hepatitis Co-infection, Lisbon, Portugal, June 2009.
Blackard J, Ma G, Rouster S, Barrett A, Shata T, Sherman K. HIV is frequently detected in liver biopsy tissue. 5th International Workshop on HIV and Hepatitis Co-infection, Lisbon, Portugal, June 2009.
Shata MT, Bartholomew KA, Rouster SD, Blackard JT, Sterling RK, Bini E, Perelson AS, Goodman ZD and Sherman KE. Strong HCV and HIV immune responses in coinfected subjects who experienced ALT flare and/or rebound HCV viral load after ART initiation. 17th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, February 2010.
| Responsible Party: | Kenneth Sherman, Principal Investigator, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00545558 History of Changes |
| Other Study ID Numbers: |
5R01AI065256-01 ( U.S. NIH Grant/Contract ) 5R01AI065256 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 15, 2007 |
| Last Updated: | August 8, 2014 |
Keywords provided by Kenneth Sherman, University of Cincinnati:
|
Antiretroviral Therapy, Highly Active Coinfection Treatment Naive |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Emtricitabine Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on August 18, 2017