Progression of HIV-Disease Under Low Dose Corticosteroids (ProCort1)

This study has been completed.
Sponsor:
Collaborators:
German Leprosy and Tuberculosis Relief Association
University of Würzburg, Germany
Action Medeor, Germany
Evangelisches Studienwerk Villigst, Germany
Georg Friedrich Rexroth Stiftung, Lohr, Germany
Information provided by (Responsible Party):
Dr. August Stich, Medical Mission Institute, Germany
ClinicalTrials.gov Identifier:
NCT01299948
First received: February 18, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
HIV Disease Progression
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial to Assess Risk and Benefit of Oral Low Dose Prednisolone for HIV Infected People Prior to the Commencement of Antiretroviral Treatment

Resource links provided by NLM:


Further study details as provided by Medical Mission Institute, Germany:

Primary Outcome Measures:
  • Time to progression of HIV disease [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The primary objective of the study is to assess the effect of the low dose prednisolone therapy on the time to progression of HIV disease. The time to progression is defined as the time between the baseline and the change of staging to advanced disease (CDC stage A3, B3 or C) or death


Secondary Outcome Measures:
  • stabilisation of CD4 count [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The total CD4 cell count, measured in number of cells per µl, should be significantly higher in the intervention group.

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The rate of survival should not differ significantly between the two groups.

  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The quality of life of participants, as measured by a standardised set of questions, should not differ significantly between the two groups.

  • Rate of co-infections [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The rate of co-infections should not be significantly higher in the intervention group.

  • Immune activation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    In vitro studies on isolated lymphocytes of patients in both arms should show significant differences in their activation status.


Enrollment: 326
Study Start Date: June 2007
Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: prednisolone
5 mg prednisolone per os daily administration
Drug: Prednisolone
5 mg prednisolone orally per day
Placebo Comparator: placebo
The placebo is designed to the equal look like the study medication.
Drug: Prednisolone
5 mg prednisolone orally per day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299948

Locations
Tanzania
Bugando Medical Center
Mwanza, Tanzania, 1370
Sponsors and Collaborators
Medical Mission Institute, Germany
German Leprosy and Tuberculosis Relief Association
University of Würzburg, Germany
Action Medeor, Germany
Evangelisches Studienwerk Villigst, Germany
Georg Friedrich Rexroth Stiftung, Lohr, Germany
Investigators
Study Director: August HR Stich, MD MSc Medical Mission Institute, Würzburg, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. August Stich, MD, MSc, Medical Mission Institute, Germany
ClinicalTrials.gov Identifier: NCT01299948     History of Changes
Other Study ID Numbers: ProCort1
Study First Received: February 18, 2011
Last Updated: March 21, 2013
Health Authority: Tanzania: Ministry of Health

Keywords provided by Medical Mission Institute, Germany:
HIV
AIDS
CD4
progression
immune activation

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2014