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Progression of HIV-Disease Under Low Dose Corticosteroids

NCT01299948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2013-03-22

No results posted yet for this study

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.

Conditions

  • HIV Disease Progression

Interventions

DRUG

Prednisolone

5 mg prednisolone orally per day

Sponsors & Collaborators

  • German Leprosy and Tuberculosis Relief Association

    collaborator OTHER

  • University of Wuerzburg

    collaborator OTHER

  • Action Medeor

    collaborator OTHER

  • Evangelisches Studienwerk Villigst, Germany

    collaborator UNKNOWN

  • Georg Friedrich Rexroth Stiftung, Lohr, Germany

    collaborator UNKNOWN

  • Medical Mission Institute, Germany

    lead OTHER

Principal Investigators

  • August HR Stich, MD MSc · Medical Mission Institute, Würzburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-03-31
Completion
2012-05-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299948 on ClinicalTrials.gov