Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients (CONTRA)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: Peginterferon alfa-2a + ribavirin in normal ALT Drug: Peginterferon alfa-2a + ribavirin in elevated ALT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- % patients with RNA-HCV negative [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | September 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Peginterferon alfa-2a + ribavirin in normal ALT
|
Drug: Peginterferon alfa-2a + ribavirin in normal ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Name: Pegasys + ribavirin
|
|
Active Comparator: 2
peginterferon alfa-2a + ribavirin in elevated ALT
|
Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Name: Pegasys + ribavirin
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Spain | |
| Hospital de Txagorritxu | |
| Vitoria, Alava, Spain, 01009 | |
| Hospital Universitari of Bellvitge | |
| Hospitalet, Barcelona, Spain, 08907 | |
| Consorci Sanitari Integral | |
| Hospitalet, Barcelona, Spain, 08907 | |
| Hospital General de Mataró | |
| Mataró, Barcelona, Spain, 08304 | |
| Consorci Sanitari de Terrassa | |
| Terrassa, Barcelona, Spain, 08227 | |
| Hospital de Donostia | |
| San Sebastián, Guipúzcoa, Spain, 20014 | |
| Hospital Xeral-Cíes | |
| Vigo, Pontevedra, Spain, 36204 | |
| Hospital de Cruces | |
| Baracaldo, Vizcaya, Spain, 48903 | |
| Hospital Clinic | |
| Barcelona, Spain, 08036 | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital San Jorge | |
| Huesca, Spain, 22004 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital de la Princesa | |
| Madrid, Spain, 28006 | |
| Hospital Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Joan XXIII | |
| Tarragona, Spain, 43007 | |
| Hospital Clínico Lozano Blesa | |
| Zaragoza, Spain, 50009 | |
| Study Chair: | Miguel Santin, Dr | Hospital Universitari of Bellvitge |
More Information
No publications provided
| Responsible Party: | Miguel Santin, Dr, Hospital Universitari de Bellvitge |
| ClinicalTrials.gov Identifier: | NCT01684787 History of Changes |
| Other Study ID Numbers: | Miguel Santín |
| Study First Received: | June 11, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Universitari de Bellvitge:
|
chronic hepatitis C normal ALT HIV/HCV patients |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites |
ClinicalTrials.gov processed this record on March 03, 2013
