Clinical trial NCT01684787: Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: chronic hepatitis C
normal ALT
HIV/HCV patients
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: % patients with RNA-HCV negative
timeFrame: 24 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: Alava
city: Hospitalet
country: Spain
facility: Consorci Sanitari Integral
state: Barcelona
city: Hospitalet
country: Spain
facility: Hospital Universitari of Bellvitge
state: Barcelona
city: Mataró
country: Spain
facility: Hospital General de Mataró
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Guipúzcoa
city: Vigo
country: Spain
facility: Hospital Xeral-Cíes
state: Pontevedra
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Huesca
country: Spain
facility: Hospital San Jorge
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Hospital Universitari of Bellvitge
name: Miguel Santin, Dr
role: STUDY_CHAIR
References: