Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV

NCT00356486 | Completed Phase 4

• 2 other identifiers: CORAL-22004 - 000907 -16
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to compare the early virological response (EVR = undetectable \[ribonucleic acid-hepatitis C virus\] RNA-HCV or a reduction of \> 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.

Conditions

HIV Infections

Keywords

Chronic Hepatitis C; Co-infection; Induction dose; HIV; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with undetectable RNA-HCV

  at week 12 after starting treatment

Secondary Outcomes (8)

• Variations of the levels of RNA-HCV

  from baseline until weeks 4, 8, and 12 of the study

• Percentage of patients with undetectable HCV RNA

  in weeks 4 and 8 of the study

• Levels of ALT

  At weeks 4, 8, and 12

• Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin.

  During the 12 weeks of follow-up

• Percentage of patients that drop out of the study for adverse effects or intolerance

  During the 12 weeks of follow-up

Study Arms (2)

A

EXPERIMENTAL

Peginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks

Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β

B

EXPERIMENTAL

Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks

Interventions

Peginterferon alfa-2a, Ribavirin, epoetin-β DRUG

Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks

A

Peginterferon alfa-2a + Ribavirin for 12 weeks DRUG

Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
• Detectable RNA-HCV plasma level genotype 1 and 4
• ALT serum activity above the upper limit of normality
• Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
• Patients with CD4 cell count \> 200 /µl
• Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.
• Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment
• Patients that do not receive HAART therapy
• Negative pregnancy test in urine or blood

You may not qualify if:

• Women currently pregnant or in the lactation period.
• Patients whose companion is pregnant.
• Therapy with interferon (IFN) or ribavirin at any previous time.
• Patients with cirrhosis in the hepatic biopsy.
• Documented suspicion by ultrasound of hepatocarcinoma.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (12)

Hospital Germans Trias i Pujol, Badalona

Badalona, Barcelona, 08916, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital General de Vic

Vic, Barcelona, 08500, Spain

Location

Hospital de Donostia

San Sebastián, Donostia, 20012, Spain

Location

Hospital General Universitario de Alicante

Alicante, 46014, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínic i Provincial

Barcelona, 08036, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Gregorio Marañón.

Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C, Chronic; Coinfection

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bonaventura Clotet, MD, PhD

  LLuita contra la Sida Foundation-HIV Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 26, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

ES (12)