NCT00057421

Brief Summary

This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 1998

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2003

Completed
Last Updated

September 18, 2007

Status Verified

August 1, 2007

First QC Date

April 1, 2003

Last Update Submit

September 17, 2007

Conditions

TuberculosisHIV Infections

Keywords

TuberculosisHIV infectionPrednisoloneSafetyImmune activation

Interventions

prednisoloneDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pulmonary TB (smear positive)
  • HIV infected
  • Residence within 20 km of Kampala city
  • Allows frequent blood specimens to be drawn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital Tuberculosis Clinic

Kampala, Uganda

Location

MeSH Terms

Conditions

TuberculosisHIV Infections

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Christopher Whalen

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 1, 2003

First Posted

April 3, 2003

Study Start

November 1, 1998

Study Completion

September 1, 2002

Last Updated

September 18, 2007

Record last verified: 2007-08

Locations

UG(1)