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Home > "T" Clinical Trials Conditions > Tuberculosis in HIV Infected Patients in Uganda  Tuberculosis in HIV Infected Patients in Uganda
Tuberculosis in HIV Infected Patients in Uganda
For Condition: HIV Infections,Tuberculosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Pulmonary TB (smear positive) - HIV infected - Residence within 20 km of Kampala city - Allows frequent blood specimens to be drawn
Total Enrollment: 190
Location and Contact Information:
Overall Study Official:
ChristopherWhalen, Principal Investigator, Case Western Reserve University
Mulago Hospital Tuberculosis Clinic
Kampala, ,
Uganda
Additional Information:
Study ID Numbers: 2 R01AI32414-08;
Study Start Date: November 1998
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057421
Other Tuberculosis Studies:
1. Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
2. Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen
3. Diagnosing Tuberculosis in HIV Infected Children in Peru
4. Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection
5. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
Related Studies:
Other Tuberculosis Clinical Trials
Other Clinical Trials
Other Kampala Clinical Trials
Tuberculosis in HIV Infected Patients in Uganda
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