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| ID | Type | Description | Link |
|---|---|---|---|
| 2004 - 000907 -16 |
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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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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.
This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).
Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| B | Experimental | Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with undetectable RNA-HCV | at week 12 after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventura Clotet, MD, PhD | LLuita contra la Sida Foundation-HIV Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol, Badalona | Badalona | Barcelona | 08916 | Spain | ||
| Consorci Sanitari de Terrassa |
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| 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 |
|
| 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 |
| Variations in levels of haemoglobin, neutrophil, and platelet count | at 4, 8, and 12 weeks with regard to baseline |
| AIDS-defining events or death | During the 12 weeks of follow-up |
| Changes in the CD4/CD8 cell count | At 4, 8, and 12 weeks of follow-up |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Hospital General de Vic | Vic | Barcelona | 08500 | Spain |
| Hospital de Donostia | San Sebastián | Donostia | 20012 | Spain |
| Hospital General Universitario de Alicante | Alicante | 46014 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clínic i Provincial | Barcelona | 08036 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Gregorio Marañón. | Madrid | 28007 | Spain |
| Hospital Ramón y Cajal | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019698 | Hepatitis C, Chronic |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006526 | Hepatitis C |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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