Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.
An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.
All co-infected patients should be an opportunity of retreatment with actually therapies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a plus ribavirin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a plus ribavirin adjusted to body weight | Drug | PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with RNA-HCV undetectable | 24 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy | At weeks 4, 12, 24 and 48 on treatment | |
| Ribavirin levels | At weeks 4, 12, 24 and 48 on treatment |
Not provided
Inclusion Criteria:
Male and female patients between 18 and 65 years of age
Anti-HCV positive
Detectable plasma HCV-RNA
Relapsers after treatment with interferon o peginterferon +/- ribavirin
HIV positive
CD4 >/= 200 cell
Patients on clinically stable liver disease with:
HBsAg negative
With antecedents of diabetes or hypertension is necessary an previous ocular exploration
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vicente Soriano, Dr | Hospital Carlos III. Madrid. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Carlos III | Madrid | Madrid | 28029 | Spain |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Impact of dose reduction peg-interferon and/or ribavirin | At weeks 4, 12, 24 and 48 on treatment |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus 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 |
| 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 |