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

Miguel Santin

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a + ribavirin in normal ALT; Drug: Peginterferon alfa-2a + ribavirin in elevated ALT

Study type: Interventional

Funder types: Other

Identifiers

NCT01684787

Miguel Santín

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

Peginterferon alfa-2a + ribavirin in normal ALT

Treatment:

Drug: Peginterferon alfa-2a + ribavirin in normal ALT

2

Active Comparator group

Description:

peginterferon alfa-2a + ribavirin in elevated ALT

Treatment:

Drug: Peginterferon alfa-2a + ribavirin in elevated ALT