NCT01299948

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

February 18, 2011

Last Update Submit

March 21, 2013

Conditions

HIV Disease Progression

Keywords

HIVAIDSCD4progressionimmune activation

Outcome Measures

Primary Outcomes (1)

  • Time to progression of HIV disease

    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

    2 years

Secondary Outcomes (5)

  • stabilisation of CD4 count

    2 years

  • Overall survival

    2 years

  • Quality of life

    2 years

  • Rate of co-infections

    2 years

  • Immune activation

    2 years

Study Arms (2)

prednisolone

ACTIVE COMPARATOR

5 mg prednisolone per os daily administration

Drug: Prednisolone

placebo

PLACEBO COMPARATOR

The placebo is designed to the equal look like the study medication.

Drug: Prednisolone

Interventions

PrednisoloneDRUG

5 mg prednisolone orally per day

placeboprednisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bugando Medical Center

Mwanza, Mwanza Region, 1370, Tanzania

Location

Related Publications (1)

  • Kasang C, Kalluvya S, Majinge C, Kongola G, Mlewa M, Massawe I, Kabyemera R, Magambo K, Ulmer A, Klinker H, Gschmack E, Horn A, Koutsilieri E, Preiser W, Hofmann D, Hain J, Muller A, Dolken L, Weissbrich B, Rethwilm A, Stich A, Scheller C. Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial. PLoS One. 2016 Jan 26;11(1):e0146678. doi: 10.1371/journal.pone.0146678. eCollection 2016.

    PMID: 26812052DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDisease Progression

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • August HR Stich, MD MSc

    Medical Mission Institute, Würzburg, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

June 1, 2007

Primary Completion

March 1, 2011

Study Completion

May 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

TA(1)