drugset / Trial / NCT01299948
Progression of HIV-Disease Under Low Dose Corticosteroids
Phase 2
Completed
326 enrolled
Medical Mission Institute, Germany
Action Medeor · collabEvangelisches Studienwerk Villigst, Germany · collabGeorg Friedrich Rexroth Stiftung, Lohr, Germany · collabGerman Leprosy and Tuberculosis Relief Association · collabUniversity of Wuerzburg · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
There has been reports that low dose prednisolone stabilizes CD4-counts in HIV infected individuals. However, until now, there are no prospective randomized studies on the use of corticosteroids in latent HIV disease. Furthermore, low dose prednisolone (5 mg/d) is not sufficient tested for the risks and benefit for HIV patients especially for those living in poor settings with a higher risk of infections. This study will assess the benefit and the safety profile for low dose prednisolone therapy for patients in a region with limited resources and high prevalence of infections.
Timeline
- Start
- 2007-06
- Primary completion
- 2011-03
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | 5 mg | Oral |