Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon alfa-2a + ribavirin in normal ALT; Drug: Peginterferon alfa-2a + ribavirin in elevated ALT

• Registration Number: NCT01684787
• Lead Sponsor: Miguel Santin

Brief Summary

In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.

Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.

The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.

In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.

In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.

This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.

The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.

Detailed Description

The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2010-06-11
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-12
• Last Update Submitted: 2012-09-12
• Study First Posted: 2012-09-13
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients over 18 years old
• Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
• CD4 > 200 cel/mL
• Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
• Negative contraception test
• Informed consent signed

Exclusion Criteria

• Pregnancy
• Any previous treatment for CHC
• Any experimental treatment in the 6 previous weeks to the inclusion
• Cirrhosis grade B or C (Child-Pugh)
• Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, ...
• Hepatic cancer
• Neutrophils < 1500 cel/mL, Platelets < 70000 cel/mL, Hemoglobin < 11 g/dL (men) or < 12 g/dL (women) previous to inclusion
• Severe psychiatric illness background
• Serum creatinin > 1,5 times the upper normal limit
• Background of Pulmonary or Cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Peginterferon alfa-2a + ribavirin in normal ALT	Peginterferon alfa-2a + ribavirin in normal ALT
2	Peginterferon alfa-2a + ribavirin in elevated ALT	peginterferon alfa-2a + ribavirin in elevated ALT

Primary Outcome Measures

Name	Time	Method
% patients with RNA-HCV negative	24 weeks after treatment

Trial Locations

Locations (18)

Hospital Xeral-Cíes; 🇪🇸 Vigo, Pontevedra, Spain

Hospital General de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Txagorritxu; 🇪🇸 Vitoria, Alava, Spain

Consorci Sanitari Integral; 🇪🇸 Hospitalet, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital de Cruces; 🇪🇸 Baracaldo, Vizcaya, Spain

Hospital Universitari of Bellvitge; 🇪🇸 Hospitalet, Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital San Jorge; 🇪🇸 Huesca, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Princesa; 🇪🇸 Madrid, Spain

Hospital de Donostia; 🇪🇸 San Sebastián, Guipúzcoa, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain