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Trial record 22 of 540 for:    IFNA2 AND RBV

Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients

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ClinicalTrials.gov Identifier: NCT02008214
Recruitment Status : Unknown
Verified December 2013 by JAIME ANDRADE VILLANUEVA, Centro Universitario de Ciencias de la Salud, Mexico.
Recruitment status was:  Not yet recruiting
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
JAIME ANDRADE VILLANUEVA, Centro Universitario de Ciencias de la Salud, Mexico

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
sustained virologic rate 24 weeks post treatment with IFNalpha 2a/RBV/PTX with genotype 1 chronic HCV infection + HIV infection [ Time Frame: SVR rate at 24 weeks after the end of therapy ]
Primary objective: is to evaluate sustained virologic response at post treatment week 24 following treatment with IFNalpha 2a/RBV/PTX with genotype 1 chronic HCV infection + HIV infection
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • grade of hepatic fibrosis [ Time Frame: Baseline and week 72 (for quick responders) or week 96 (for non-quick responders) ]
    The liver stiffness (hepatic fibrosis) will be measured by transient elastography and the APRI index on the baseline visit and then at the follow up visit after treatment, which will be after 72 weeks, for patients that turn out to be quick responders; or 96 weeks, for patients that turn out to be non-quick responders.
  • rapid virologic response (RVR) and extended rapid virologic response (eRVR) rates [ Time Frame: RVR at week 4 and eRVR at week 48 post treatment ]
    secondary objective (2): Evaluate rapid virologic response (RVR) and extended rapid virologic response (eRVR)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 6, 2013)
Percentage of patients with CC genotype on the IL28B rs12979860 polymorphism [ Time Frame: week 72 ]
We will compare the percentage of patients with CC genotype among patients that achieved sustained virologic response and those who did not achieved it. This is to confirm if the intervention provides a beneficial effect, irrespectively of host genetic factors.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients
Official Title  ICMJE Efficacy of Pentoxyfylline Addition to a Treatment Scheme Based on Interferon Alpha and Ribavirin on Hepatitis C Virus Coinfected HIV Patients, Considering Interleukin 28B Polymorphism rs12979860
Brief Summary

Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54 to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected patients. A previous study on HCV monoinfected patients showed that the addition of pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV coinfected patients.

On the other hand, other factors such as host genetics, have proved to influence treatment response on HCV infected patients. The best described genetic factor so far is the interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype provides an almost twice increase on SVR than the rest of the genotypes.

Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype 1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860.

HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART), with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or higher will be included. Patients will be randomized on one of two groups:

  • Group A: IFN alpha 2a + RBV + PTX
  • Group B: IFN alpha 2a + RBV + placebo

Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks (for non rapid responses). Outcome measures will be the following:

  • SVR rate 24 weeks after the end of treatment
  • Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient elastography and the AST to platelet ratio index (APRI index)
  • IL28B rs12979860 genotype

The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate and fibrosis progression irrespectively of IL28B rs12979860 genotype.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepacivirus
  • HIV Infections
Intervention  ICMJE
  • Drug: Pentoxifylline
    Addition of pentoxifylline to current HCV treatment
  • Drug: Placebo
    Placebo matching pentoxifylline dosage
Study Arms  ICMJE
  • Experimental: PTX
    IFN 180 micrograms subcutaneous weekly RBV 400 mg each 12 h, oral PTX 400 mg each 12 h, oral
    Intervention: Drug: Pentoxifylline
  • Placebo Comparator: Placebo
    IFN 180 micrograms subcutaneous weekly RBV 400 mg each 12 h, oral Placebo oral daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 6, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV/HCV coinfected patients
  • 18 to 65 years old
  • currently receiving HAART
  • non-pregnant women
  • HIV infection controlled as: undetectable viral load (<40 copies/mL) for at least 8 months and T helper cells count of 200 cells/μL or above
  • no contraindications to IFN alpha2a, RBV or PTX treatment
  • sign informed consent form
  • laboratory parameters within acceptable ranges

Exclusion Criteria:

  • Women that present a positive pregnancy test during the study
  • Patients that for any reason no longer wish to receive IFN alpha2a, RBV or PTX treatment
  • Serious adverse events that prevent to continue IFN alpha2a, RBV or PTX treatment; such as severe neutropenia, severe thrombocytopenia or severe anemia
  • Presence of an opportunistic infection or malignancy that requires treatment with drugs interacting with IFN alpha2a, RBV or PTX
  • Patients that fail to adhere to treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02008214
Other Study ID Numbers  ICMJE PTX-HCV/HIV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JAIME ANDRADE VILLANUEVA, Centro Universitario de Ciencias de la Salud, Mexico
Study Sponsor  ICMJE Centro Universitario de Ciencias de la Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centro Universitario de Ciencias de la Salud, Mexico
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP