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Tuberculosis in HIV Infected Patients in Uganda

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: April 1, 2003
Last updated: September 17, 2007
Last verified: August 2007

April 1, 2003
September 17, 2007
November 1998
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Complete list of historical versions of study NCT00057421 on Archive Site
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Tuberculosis in HIV Infected Patients in Uganda
Impact of Tuberculosis on HIV Infection in Uganda

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.

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.

Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Tuberculosis
  • HIV Infections
Drug: prednisolone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2002
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Inclusion Criteria

  • Pulmonary TB (smear positive)
  • HIV infected
  • Residence within 20 km of Kampala city
  • Allows frequent blood specimens to be drawn
18 Years to 60 Years
Contact information is only displayed when the study is recruiting subjects
R01AI32414, R01 AI32414
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Christopher Whalen Case Western Reserve University
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP