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Tuberculosis in HIV Infected Patients in Uganda

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ClinicalTrials.gov Identifier: NCT00057421
Recruitment Status : Completed
First Posted : April 3, 2003
Last Update Posted : September 18, 2007
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Tuberculosis HIV Infections Drug: prednisolone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Impact of Tuberculosis on HIV Infection in Uganda
Study Start Date : November 1998
Study Completion Date : September 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057421

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Mulago Hospital Tuberculosis Clinic
Kampala, Uganda
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Christopher Whalen Case Western Reserve University
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ClinicalTrials.gov Identifier: NCT00057421    
Other Study ID Numbers: R01AI032414 ( U.S. NIH Grant/Contract )
R01AI032414 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2003    Key Record Dates
Last Update Posted: September 18, 2007
Last Verified: August 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV infection
Immune activation
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents