skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00100581, ACTG A5184
  • Concluido

Propósito del estudio

A significant proportion of HIV infected people in the U.S. are also infected with hepatitis C virus (HCV). The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin (PEG/RBV). Hypothesis: In HCV/HIV coinfected patients with CD4 counts of 300 cells/mm3 or greater, initial HIV therapy followed by concurrent HIV and HCV therapy will result in higher early HCV virologic response rates and therefore ultimately higher sustained HCV virologic response rates compared to HCV therapy without HIV therapy.

Afección:
Infecciones por el VIH
Hepatitis C

Detalles del estudio

An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One infection often accelerates the progression of the other, and effective management strategies for both infections need to be developed for HCV/HIV coinfected patients. This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone.



This study will last up to 102 weeks. Participants will be randomly assigned to one of two arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.



Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in Arm B will be followed for an additional 48 weeks with no treatment.



There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all visits, and urine collection will occur at selected visits. Participants will also be asked to complete adherence questionnaires. Participants in this study are encouraged to also enroll in ACTG A5128.An estimated 15% to 30% of HIV infected people in the U.S. are also infected with HCV. Since the introduction of antiretroviral therapy (ART) for the treatment of HIV, HCV infection has emerged as a major cause of morbidity and mortality in HCV/HIV coinfected patients. One infection often accelerates the progression of the other, and effective management strategies for both infections need to be developed for HCV/HIV coinfected patients. This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone.



This study will last up to 102 weeks. Participants will be randomly assigned to one of two arms. Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) and either efavirenz (EFV) or lopinavir/ritonavir (LPV/r). If deemed eligible, Arm A participants will continue their ART regimen and begin a concurrent PEG/RBV regimen for up to 48 weeks. At Week 48, participants in Arm A will stop PEG/RBV and will be followed for an additional 24 weeks on ART alone.



Arm B participants will receive PEG/RBV alone for up to 48 weeks. At Week 48, participants in Arm B will be followed for an additional 48 weeks with no treatment.



There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants. Blood collection and clinical assessment will occur at all visits, and urine collection will occur at selected visits. Participants will also be asked to complete adherence questionnaires. Participants in this study are encouraged to also enroll in ACTG A5128.

Criterios de inclusión

    for Step 1:
    • HIV infected
    • HIV viral load of greater than 1000 copies/ml within 45 days of study entry
    • HCV genotype 1 infected
    • CD4 count of 300 cells/mm3 or greater within 45 days prior to study entry
    • Willing to accept randomly assigned study treatment
    • Willing to use acceptable forms of contraception during the study and for 6 months after stopping all study medications
    • Chronic liver disease consistent with chronic viral hepatitis as indicated by liver biopsy within 2 years prior to study entry. Participants with cirrhosis must have a serum alpha-fetoprotein of 100 ng/ml or less and a Child-Pugh score of 6 or higher within 45 days prior to study entry to be eligible for this study.

Criterios de exclusión

    for Step 1:
    • Hepatitis B surface antigen positive within 45 days prior to study entry
    • HCV genotype other than genotype 1 at any time prior to study entry
    • Any medical conditions associated with chronic liver disease other than HCV (e.g., genetic hemochromatosis, autoimmune hepatitis)
    • Prior use of intravenous or subcutaneous interferon for more than 2 weeks total at any time prior to study entry
    • Known allergy/sensitivity to study drugs or their formulations. Participants who are allergic/sensitive to either EFV or LPV/r, but not both, are not excluded.
    • Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study. Participants in methadone programs are not excluded, but may require methadone dose changes during the study.
    • Received ART for more than 7 consecutive days within the 6 months prior to study entry
    • Received 3TC, TDF, a protease inhibitor, or nonnucleoside reverse transcriptase inhibitor for more than 31 days cumulative therapy at any time prior to study entry
    • Need to start ART at the time of study entry
    • Uncontrolled diabetes mellitus within 30 days prior to study entry
    • Previous suicide attempt or hospitalization for a psychiatric illness within 2 years prior to study entry. Participants with psychiatric disease, especially depression, uncontrolled with medication are not eligible for the study.
    • Prior or current evidence of immunologically mediated disease (e.g., inflammatory bowel disease, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
    • Chronic pulmonary disease associated with functional limitation
    • Severe cardiac disease within 24 weeks prior to study entry
    • History of severe retinopathy due to diabetes, hypertension, cytomegalovirus, or macular degeneration
    • History of major organ transplantation
    • Severe illness, cancer, or other conditions that would interfere with the study
    • Any systemic antineoplastic or immunomodulatory treatment (except epoetin alfa or granulocyte colony-stimulating factor [G-CSF]) or radiation within 24 weeks of study entry. Participants who anticipate the need to begin such treatment during the study are not eligible.
    • History of hemoglobinopathy (e.g., thalassemia, sickle cell anemia)
    • Active gout
    • Requirement for certain medications
    • Evidence of decompensated liver disease, such as history or presence of ascites, jaundice, bleeding varices, or hepatic encephalopathy
    • Has a pregnant partner
    • Pregnancy or breastfeeding

Centros de estudio/contactos

New York

    Columbia Univ., HIV Prevention and Treatment Medical Ctr., New York, New York, 10032-3784, United States

Texas

    Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic, Dallas, Texas, 75235-9173, United States

Actualizado: 20 de diciembre del 2005

Volver arriba