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.
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
|
||
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 |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
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 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
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 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
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 | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01680094 -
Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART
|
Phase 1/Phase 2 |