None listed
Conditions
Interventions
PEG-Intron 3mcg Type of group
The medication is administered subcutaneously based on body weight for 48 weeks
Group name:placebo Type of group
The placebo is administered subcutaneously based on body weight for 48 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: HIV positive; history of virological failure in at least 2 antiretroviral regimens including exposure to at least one nudeoside reverse transcriptase inhibitor, a non-nudeide reverse transcriptase inhibitor, and a protease inhibitor; > 400 and 75,000 u / L, hemoglobin> 9 gm / dL, absolute neutrophil count> 1000 / uL.
Exclusion criteria
Exclusion criteria: Current treatment with ribavirin; Subjects with a diagnosis or history of moderate or severe depression that requires current psychiatric intervention. Women of childbearing age who are breastfeeding, pregnant or not use adequate contraception; concomitant use of immunosuppressants or cytotoxic agents; a history of seizures that require the use of anticonvulsants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HIV-1 RNA Measure:Modification in log10 of HIV-1 RNA from the beginning until the end of Week 24 of treatment with PEG-Intron. Timepoints:24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:CD4 Measure:change in the absolute count and CD4 percentage from Start to Week 24. Timepoints:24 week | — |
Countries
Peru, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed