Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 de Valme
Sevilla, Spain, 41014
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital Virgen Macarena
Sevilla, Spain, 41008
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:
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis C
HIV Infections
Infection
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014