drugset / Trial / NCT00215852
A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.
Timeline
- Start
- 2005-07
- Primary completion
- 2009-04
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alferon LDO | Protein / enzyme biologic | 500 iu | Oral |
| Comparator | Alferon LDO | Protein / enzyme biologic | 1000 iu | Oral |
| Comparator | Alferon LDO | Protein / enzyme biologic | 2000 iu | Oral |