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:
Collaborator:
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00545558
First received: October 15, 2007
Last updated: July 20, 2012
Last verified: July 2012

October 15, 2007
July 20, 2012
April 2006
August 2011   (final data collection date for primary outcome measure)
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 ]
Underlying patterns of liver injury and hepatitis C virus (HCV) viral changes after antiretroviral therapy (ART) initiation. [ Time Frame: At the end of the study ]
Complete list of historical versions of study NCT00545558 on ClinicalTrials.gov Archive Site
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Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV
Antiretroviral Therapy and the Hepatitis C Virus

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • HIV Infections
  • 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
Experimental: 1
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.
Interventions:
  • Drug: Efavirenz
  • Drug: Emtricitabine/Tenofovir disoproxil fumarate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545558
5R01AI065256-01, 5R01AI065256
No
Kenneth Sherman, University of Cincinnati
University of Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kenneth E. Sherman, MD, PhD Unviersity of Cincinnati
University of Cincinnati
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP