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

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ClinicalTrials.gov Identifier: NCT00612755
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Sponsor:
Information provided by:
Hospital Clinico Universitario San Cecilio

Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infections Hepatitis C Drug: Peginterferon alfa-2a + ribavirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. % of patients with RNA-HCV undetectable [ Time Frame: at 48 week of study (24 weeks after the end of treatment period of trial). ]

Secondary Outcome Measures :
  1. % of percentage of patients with RNA-HCV undetectable [ Time Frame: 24 weeks of trial period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612755


Locations
Show Show 19 study locations
Sponsors and Collaborators
Hospital Clinico Universitario San Cecilio
Investigators
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Study Chair: José Hernández-Quero, Dr Hospital Clínico Universitario San Cecilio
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Responsible Party: José Hernández-Quero, Hospital Clinico Universitario San Cecilio
ClinicalTrials.gov Identifier: NCT00612755    
Other Study ID Numbers: Extrados
2004-004948-45
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008
Keywords provided by Hospital Clinico Universitario San Cecilio:
chronic hepatitis C
co-infection
extend treatment
co-infected HIV-HCV
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents