Clinical Trials Logo
  1. Home
  2. HIV Infection
  3. NCT01006031

Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4

HIV Infection Clinical Trial

Official title:
Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy.

Clinical Trial Summary

Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.

(*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment.

Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients.

Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled.

The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01006031
Study type Interventional
Source Sociedad Andaluza de Enfermedades Infecciosas
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2009
Completion date December 2011
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02663856 - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed NCT02659306 - Metformin Immunotherapy in HIV Infection Phase 1
Completed NCT02921516 - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings N/A
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Completed NCT02663869 - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed NCT02846402 - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda N/A
Completed NCT02564341 - Targeting Effective Analgesia in Clinics for HIV - Intervention N/A
Active, not recruiting NCT02302950 - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas N/A
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01830595 - Lactoferrin Treatment in HIV Patients Phase 2
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT02269605 - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment Phase 1
Completed NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Completed NCT02118168 - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 N/A
Completed NCT02527135 - Text Messaging to Improve HIV Testing Among Young Women in Kenya N/A
Completed NCT02525146 - Birmingham Access to Care Study N/A
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Active, not recruiting NCT02602418 - Neural Correlates of Working Memory Training for HIV Patients N/A
Completed NCT01702974 - Immune Reconstitution in HIV Disease (IREHIV) Phase 2