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

Chronic Hepatitis C Clinical Trial

— CONTRA  

Official title:

Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684787
• Other study ID #: Miguel Santín
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2010
• Last updated: September 12, 2012
• Start date: September 2006
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a + ribavirin in normal ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
• Peginterferon alfa-2a + ribavirin in elevated ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Baracaldo	Vizcaya
Spain	Hospital Clinic	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Consorci Sanitari Integral	Hospitalet	Barcelona
Spain	Hospital Universitari of Bellvitge	Hospitalet	Barcelona
Spain	Hospital San Jorge	Huesca
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital General de Mataró	Mataró	Barcelona
Spain	Hospital de Donostia	San Sebastián	Guipúzcoa
Spain	Hospital Joan XXIII	Tarragona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Xeral-Cíes	Vigo	Pontevedra
Spain	Hospital de Txagorritxu	Vitoria	Alava
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Miguel Santin

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% patients with RNA-HCV negative		24 weeks after treatment	No