Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
This study has been completed.
Sponsor:
Hospital Clinico Universitario San Cecilio
Information provided by:
Hospital Clinico Universitario San Cecilio
ClinicalTrials.gov Identifier:
NCT00612755
First received: January 29, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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Purpose
A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.
The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.
In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.
The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.
Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Hepatitis C |
Drug: Peginterferon alfa-2a + ribavirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4 |
Resource links provided by NLM:
Further study details as provided by Hospital Clinico Universitario San Cecilio:
Primary Outcome Measures:
- % of patients with RNA-HCV undetectable [ Time Frame: at 48 week of study (24 weeks after the end of treatment period of trial). ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- % of percentage of patients with RNA-HCV undetectable [ Time Frame: 24 weeks of trial period ] [ Designated as safety issue: Yes ]
| Enrollment: | 43 |
| Study Start Date: | October 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
|
Drug: Peginterferon alfa-2a + ribavirin
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Other Name: Pegasys
|
| No Intervention: 2 |
Detailed Description:
To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
- RNA-HCV positive at 48 week before study and genotype 1 or 4.
- HIV-1 positive: ELISA y Western-blot.
- Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion Criteria:
- Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
- Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
- More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612755
Locations
| Spain | |
| Hospital de Txagorritxu | |
| Vitoria, Alava, Spain, 01009 | |
| Hospital de Bellvitge | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Hospital de Jerez | |
| Jerez de la Frontera, Cádiz, Spain, 11407 | |
| Hospital Insular | |
| Las Palmas, Gran Canaria, Spain, 35016 | |
| Hospital de Donostia | |
| San Sebastián, Guipúzcoa, Spain, 20014 | |
| Complejo Hospitalario Universitario | |
| Santiago, La Coruña, Spain, 15705 | |
| Fundación Hospital de Alcorcón | |
| Alcorcón, Madrid, Spain, 28922 | |
| Hospital Son Dureta | |
| Palma de Mallorca, Mallorca, Spain, 07014 | |
| Hospital Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Puerta del Mar | |
| Cádiz, Spain, 11009 | |
| Hospital Clínico Universitario San Cecilio | |
| Granada, Spain, 18013 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital Virgen Macarena | |
| Sevilla, Spain, 41008 | |
| Hospital de Valme | |
| Sevilla, Spain, 41014 | |
| Consorcio Hospital General | |
| Valencia, Spain, 46014 | |
| Hospital Clínico de Valladolid | |
| Valladolid, Spain, 47011 | |
Sponsors and Collaborators
Hospital Clinico Universitario San Cecilio
Investigators
| Study Chair: | José Hernández-Quero, Dr | Hospital Clínico Universitario San Cecilio |
More Information
No publications provided
| Responsible Party: | José Hernández-Quero, Hospital Clinico Universitario San Cecilio |
| ClinicalTrials.gov Identifier: | NCT00612755 History of Changes |
| Other Study ID Numbers: | Extrados, 2004-004948-45 |
| Study First Received: | January 29, 2008 |
| Last Updated: | January 29, 2008 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinico Universitario San Cecilio:
|
chronic hepatitis C co-infection extend treatment co-infected HIV-HCV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus 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 Molecular Mechanisms of Pharmacological Action Immunologic Factors |
ClinicalTrials.gov processed this record on March 03, 2013
