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

NCT ID: NCT02008214

Last Updated: 2013-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Hepacivirus; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PTX

IFN 180 micrograms subcutaneous weekly RBV 400 mg each 12 h, oral PTX 400 mg each 12 h, oral

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

Addition of pentoxifylline to current HCV treatment

Placebo

IFN 180 micrograms subcutaneous weekly RBV 400 mg each 12 h, oral Placebo oral daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching pentoxifylline dosage

Interventions

Pentoxifylline

Addition of pentoxifylline to current HCV treatment

Intervention Type: DRUG

Placebo

Placebo matching pentoxifylline dosage

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitario de Ciencias de la Salud, Mexico

OTHER

Sponsor Role: lead

Responsible Party

JAIME ANDRADE VILLANUEVA

Professor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Civil de Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Central Contacts

Jaime Andrade-Villanueva, MD, MSc

Role: CONTACT

andradevjav@gmail.com

+52 33 36147586

Luz A Gonzalez-Hernandez, MD, PhD

Role: CONTACT

luceroga08@gmail.com

+52 33 36147586

Facility Contacts

Mara Llamas-Covarrubias, BSc, PhD

Role: primary

mara.covarrubias@gmail.com

+52 33 36147586

Other Identifiers

PTX-HCV/HIV

Identifier Type: -

Identifier Source: org_study_id