Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV (ART and HCV)
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Purpose
| 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 |
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545558
| 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 | |
| Principal Investigator: | Kenneth E. Sherman, MD, PhD | Unviersity of Cincinnati |
More Information
Publications:
| 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 ) |
| First Submitted: | October 15, 2007 |
| First Posted: | October 17, 2007 |
| Last Update Posted: | August 12, 2014 |
| Last Verified: | August 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 |