Clinical trial NCT00470210: Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
Official title: Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
HIV Infections
Keywords: Ribavirin
non-responders
HCV co-infected patients
sustained virological response
Treatment Experienced
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2007-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

Detailed description: The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.

The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.

The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of \< 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

Eligibility criteria: Inclusion Criteria:

* HIV-infected patients coinfected with HCV genotypes 1 or 4
* Persistent transaminase elevation
* Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.

Exclusion Criteria:

* Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
* Patients with Child-Pugh B or C cirrhosis

Primary outcomes:
measure: Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
timeFrame: 24 weeks after finishing treatment
Secondary outcomes:
measure: Changes in serum HCV-RNA titers
timeFrame: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
measure: Percentage of patients with serum HCV-RNA loads of < 50 IU/mL
timeFrame: at weeks 4, 8, 12, 24, and 48
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Bonaventura Clotet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Cristina Tural, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: