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Completed

NCT Number: NCT00553930

Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients

Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.

Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.

Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point wall be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio

Seville, Sevilla, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age older than 18 years
  • HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
  • Women of child-bearing age: negative pregnancy test
  • Ability to understand and sign a written consent form

Exclusion criteria

  • Previous interferon treatment
  • Pregnancy or breastfeeding
  • Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
  • Creatinine clearance < 50 ml/min, according to Cockcroft-Gault
  • Decompensated liver disease
  • History of organ transplantation
  • Concomitant treatment with immunomodulators or didanosine
  • Alcohol abuse or use of other recreational drugs
  • History of severe psychiatric conditions
  • Autoimmune diseases
  • Inability to understand and sign a written consent form

Treatment and study plan

Pegylated interferon alfa-2a and ribavirin

Drug

All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures.

Other names: Pegasys, Copegus

Pegylated interferon alfa 2a and Ribavirin

Drug

Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures.

Other names: Pegasis (TM), Copegus (TM)

Primary outcomes

  1. Sustained viral response(undetectable serum HCV-RNA)

    Time frame: 24 weeks after the cessation of treatment

Secondary outcomes

  1. Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.

    Time frame: Throughout treatment and 24 weeks after finishing it

Sponsors and collaborators

Lead sponsor

Sociedad Andaluza de Enfermedades Infecciosas

Network

Registry information

Official study title

Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients.

Acronym: SAEI_IFN_1

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2007
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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