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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01684787

Acronym

CONTRA

Enrollment

Registered

2012-09-13

Start date

2006-09-30

Completion date

2011-06-30

Last updated

2012-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

chronic hepatitis C, normal ALT, HIV/HCV patients

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.

Interventions

DRUGPeginterferon alfa-2a + ribavirin in normal ALT

peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily

DRUGPeginterferon alfa-2a + ribavirin in elevated ALT

peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
% patients with RNA-HCV negative	24 weeks after treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026