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

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 Outcome Measures ICMJE; (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 Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	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