Completed

NCT Number: NCT01684787

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Txagorritxu, Vitoria-Gasteiz, Alava, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a + ribavirin in normal ALT

Drug

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

Other names: Pegasys + ribavirin

Peginterferon alfa-2a + ribavirin in elevated ALT

Drug

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

Other names: Pegasys + ribavirin

Primary outcomes

% patients with RNA-HCV negative

Time frame: 24 weeks after treatment

Sponsors and collaborators

Lead sponsor

Miguel Santin

Other

Registry information

Official study 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

Acronym: CONTRA

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Sep 13, 2012
Registry last updated: Sep 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed