Tuberculosis in HIV Infected Patients in Uganda

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00057421
First received: April 1, 2003
Last updated: September 17, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Tuberculosis
HIV Infections
Drug: prednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Impact of Tuberculosis on HIV Infection in Uganda

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 190
Study Start Date: November 1998
Estimated Study Completion Date: September 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Pulmonary TB (smear positive)
  • HIV infected
  • Residence within 20 km of Kampala city
  • Allows frequent blood specimens to be drawn
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057421

Locations
Uganda
Mulago Hospital Tuberculosis Clinic
Kampala, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher Whalen Case Western Reserve University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057421     History of Changes
Other Study ID Numbers: R01AI32414, R01 AI32414
Study First Received: April 1, 2003
Last Updated: September 17, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tuberculosis
HIV infection
Prednisolone
Safety
Immune activation

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014