Progression of HIV-Disease Under Low Dose Corticosteroids

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Mission Institute, Germany
• Collaborators: Action Medeor; Evangelisches Studienwerk Villigst, Germany; Georg Friedrich Rexroth Stiftung, Lohr, Germany; German Leprosy and Tuberculosis Relief Association; University of Wuerzburg
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• HIV positivity. The HIV infection has to be confirmed according to WHO guidelines.

• Patients must have signed a consent form prior to beginning protocol specific procedures.

• Adult male and female patients, age ≥18 years. Female patients of childbearing potential must have a negative pregnancy test at study entry.

• Patients must have a stage of HIV disease not yet requiring ARV therapy, defined by CDC stage A1, 2 or B1, 2.

• Patients must have a CD4 cell count ≥ 300 cells / µl.

• No AIDS defining symptoms.

• Patients must have a WHO performance status of 0,1,2

Exclusion Criteria:

• Prior ARV therapy.

• Active tuberculosis.

• Abnormal laboratory results especially glucose level >160 mg/dl, liver enzymes AST and/or ALT ≥ 1,5 x ULN, bilirubin ≥ 4 x ULN, alkaline phosphatase ≥ 5 x ULN, creatinine ≥ 2 mg/dl (176,8 µmol)

• Serious other diseases including psychiatric disorders