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

Information source: Hospital Universitari de Bellvitge
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Peginterferon alfa-2a + ribavirin in normal ALT (Drug); Peginterferon alfa-2a + ribavirin in elevated ALT (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Miguel Santin

Official(s) and/or principal investigator(s):
Miguel Santin, Dr, Study Chair, Affiliation: Hospital Universitari of Bellvitge

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.

Clinical Details

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

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

Primary outcome: % patients with RNA-HCV negative

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hospital Clinic, Barcelona 08036, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Santa Creu i Sant Pau, Barcelona 08025, Spain

Hospital San Jorge, Huesca 22004, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Hospital Clínico San Carlos, Madrid 28040, Spain

Hospital de la Princesa, Madrid 28006, Spain

Hospital Ramón y Cajal, Madrid 28034, Spain

Hospital Joan XXIII, Tarragona 43007, Spain

Hospital Clínico Lozano Blesa, Zaragoza 50009, Spain

Hospital de Txagorritxu, Vitoria, Alava 01009, Spain

Consorci Sanitari Integral, Hospitalet, Barcelona 08907, Spain

Hospital Universitari of Bellvitge, Hospitalet, Barcelona 08907, Spain

Hospital General de Mataró, Mataró, Barcelona 08304, Spain

Consorci Sanitari de Terrassa, Terrassa, Barcelona 08227, Spain

Hospital de Donostia, San Sebastián, Guipúzcoa 20014, Spain

Hospital Xeral-Cíes, Vigo, Pontevedra 36204, Spain

Hospital de Cruces, Baracaldo, Vizcaya 48903, Spain

Additional Information

Starting date: September 2006
Last updated: September 12, 2012

Page last updated: August 23, 2015

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