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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00545558 |
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 |
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Hepatitis C HIV Infections |
Drug: Efavirenz Drug: Emtricitabine/Tenofovir disoproxil fumarate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Antiretroviral Therapy and the Hepatitis C Virus |
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 |
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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.
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diane Daria, RN | 513-584-5245 | Diane.Daria@uc.edu |
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 |
Principal Investigator: | Kenneth E. Sherman, MD, PhD | Unviersity of Cincinnati |
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 |
Antiretroviral Therapy, Highly Active Coinfection Treatment Naive |
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 |
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 |