None listed
Conditions
Interventions
1,5 pg/kg PEG Intron Type of group
PEG-Intron will be administered subcutaneously once a week until the subject has a virological failure or intolerance to the drug, or until he decides to stop the treatment. The study is expected to continue for approximately 24 months.
Group name:3,0 pg/kg PEG-lntron. Type of group
PEG-Intron will be administered subcutaneously once a week until the subject has a virological failure or intolerance to the drug, or until he decides to stop the treatment. The study is expected to continue for approximately 24 months.
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must receive a HAART regimen at present. The following laboratory parameters must be met: Platelet count> 75,000/mm3 Hemoglobin> 9 gm / dl Absolute neutrophil count> 1,000/mm3 Creatinine <1.5 times the upper limit of normal SGOT / SGPT <5 times the normal upper limit
Exclusion criteria
Exclusion criteria: People who are participating in clinical studies of drugs currently in research, or have done so in the previous month. Subjects with a history of hypersensitivity to interferons. Subjects with a history of moderate or severe depression, dementia, or other major psychiatric conditions that require medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse event of any medical manifestation or unfavorable and unintentional sign presented by a subject to whom a pharmaceutical, biological product (in any dose), or a medical device was administered, regardless of whether or not it is related to the use of that product. Measure:safety and long-term tolerability that will be reflected in the laboratory parameters and in the clinical state of the subject. Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Brazil, Germany, Mexico, Peru, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed