Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
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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 |
- % 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 ]
- % 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
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 |
Study Chair: | José Hernández-Quero, Dr | Hospital Clínico Universitario San Cecilio |
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