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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005554-74 |
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| Name | Class |
|---|---|
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week | Drug | Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL | 24 weeks after finishing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum HCV-RNA titers | between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment | |
| Percentage of patients with serum HCV-RNA loads of < 50 IU/mL | at weeks 4, 8, 12, 24, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventura Clotet, MD, PhD | Germans Trias i Pujol Hospital | Principal Investigator |
| Cristina Tural, MD, PhD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital del Mar |
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| Ribavirin (Copegus®) 1600 mg/day | Drug | Ribavirin (Copegus®) 1600 mg/day |
|
| Epoetin β (450 UI/kg/week) | Drug | Epoetin β (450 UI/kg/week) |
|
| Barcelona |
| 08003 |
| Spain |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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