Tuberculosis in HIV Infected Patients in Uganda
Primary Purpose
Tuberculosis, HIV Infections
Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring Tuberculosis, HIV infection, Prednisolone, Safety, Immune activation
Eligibility Criteria
Inclusion Criteria Pulmonary TB (smear positive) HIV infected Residence within 20 km of Kampala city Allows frequent blood specimens to be drawn
Sites / Locations
- Mulago Hospital Tuberculosis Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00057421
First Posted
April 1, 2003
Last Updated
September 17, 2007
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00057421
Brief Title
Tuberculosis in HIV Infected Patients in Uganda
Official Title
Impact of Tuberculosis on HIV Infection in Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
Detailed Description
Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis (TB) is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls. Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (TNF alpha) are over-expressed during the course of TB and stimulate viral replication in latently infected cells, possibly leading to greater viral load.
Glucocorticoids are potent inhibitors of cytokines, including TNF, and clinicians have extensive experiences with their use in HIV infection. Although corticosteroid use in HIV infection has a record of safety, the safety and bioavailability of corticosteroids in HIV/TB coinfection has not been established.
This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone. The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. Although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV Infections
Keywords
Tuberculosis, HIV infection, Prednisolone, Safety, Immune activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
190 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisolone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Pulmonary TB (smear positive)
HIV infected
Residence within 20 km of Kampala city
Allows frequent blood specimens to be drawn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Whalen
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital Tuberculosis Clinic
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Tuberculosis in HIV Infected Patients in Uganda
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