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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 is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), September 2008
First Received: October 15, 2007   Last Updated: January 22, 2009   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00545558
  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 II

MedlinePlus related topics: AIDS AIDS Medicines Hepatitis Hepatitis C
Drug Information available for: Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Antiretroviral Therapy and the Hepatitis C Virus

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Underlying patterns of liver injury and hepatitis C virus (HCV) viral changes after antiretroviral therapy (ART) initiation [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive ART consisting of efavirenz and the coformulation 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 coformulation of emtricitabine and tenofovir 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
Genders Eligible for Study:   Both
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/microl. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545558

Contacts
Contact: Diane Daria, RN 513-584-5245 Diane.Daria@uc.edu

Locations
United States, Ohio
General Clinical Research Center (GCRC), OH site Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Diane Daria, RN     513-584-5245        
Principal Investigator: Kenneth E. Sherman, MD, PHD            
United States, Virginia
Virginia Commonwealth University, School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Kathleen Genther, RN     804-827-0588        
Principal Investigator: Richard K. Sterling, MD, MSc            
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth E. Sherman, MD, PhD Unviersity of Cincinnati
  More Information

Additional Information:
Publications:
Responsible Party: University of Cincinnati ( Kenneth E. Sherman, MD, PhD )
Study ID Numbers: 5R01AI065256-01, 5 R01 AI065256, 5 R01 AI065256-01
Study First Received: October 15, 2007
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00545558     History of Changes
Health Authority: United States: Federal Government;   United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiretroviral Therapy, Highly Active
Coinfection
Treatment Naive

Study placed in the following topic categories:
Efavirenz
Sexually Transmitted Diseases, Viral
Liver Diseases
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Emtricitabine
HIV Infections
Sexually Transmitted Diseases
Tenofovir
Hepatitis C
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Liver Diseases
Slow Virus Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Emtricitabine
Therapeutic Uses
Tenofovir
Hepatitis C
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Hepatitis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 06, 2009