Tuberculosis in HIV Infected Patients in Uganda
|ClinicalTrials.gov Identifier: NCT00057421|
Recruitment Status : Completed
First Posted : April 3, 2003
Last Update Posted : September 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis HIV Infections||Drug: prednisolone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Tuberculosis on HIV Infection in Uganda|
|Study Start Date :||November 1998|
|Estimated Study Completion Date :||September 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057421
|Mulago Hospital Tuberculosis Clinic|
|Principal Investigator:||Christopher Whalen||Case Western Reserve University|