A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b (IFN Alfa-2b) in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C (HCV) and Advanced Human Immunodeficiency Virus (HIV) Infections
Interferon alfa-2b
+ Zidovudine
+ Zalcitabine
Infections transmises par le sang+21
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined. Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.10 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 13 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Concurrent Medication: Allowed: Treatment or suppression of opportunistic infections with standard drugs. Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines. Clinically indicated antibiotics. Short courses of steroids (< 21 days) for acute problems not related to hepatitis C. Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives. Patients must have: HIV positivity. Documented hepatitis C virus. CD4 count <= 200 cells/mm3. No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C. Willingness to be followed for the duration of treatment and follow-up period. Prior Medication: Allowed: Prior AZT, ddI, and ddC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Hepatitis B (HBsAg positive). Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160). Wilson's disease. alpha-1 antitrypsin deficiency. Hemochromatosis. Malignancy requiring systemic chemotherapy. Concurrent Medication: Excluded: Nonnucleoside analog therapy for HIV. Biologic response modifiers. Systemic cytotoxic chemotherapy. Chronic systemic steroid use. Concurrent Treatment: Excluded: Radiation therapy other than local irradiation to the skin. Prior Medication: Excluded: Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration). Acute therapy for an infection within 2 weeks prior to study entry.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United StatesNY Univ. HIV/AIDS CRS
New York, United States