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Sponsored by: |
Ottawa Health Research Institute |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00414414 |
The purpose of this study is to determine if 30-day survival will be improved with addition of prednisone to standard tuberculosis (TB) therapy.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis HIV Infections |
Drug: Prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized, Prospective Double Blind Placebo Control Clinical Trial of Prednisone as Adjunctive Therapy for the Treatment of Hospitalized Patients With Pulmonary TB and HIV Co-Infection |
Estimated Enrollment: | 412 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2007 |
Tuberculosis (TB) is the leading cause of death in people infected with HIV worldwide. South Africa has one of the highest rates of tuberculosis and HIV in sub Saharan Africa and the world. Infection with HIV can result in activation of the latent form of TB to its active form. In places like sub Saharan Africa where the HIV rates are very high TB has spread with incredible vigor. In order to study this phenomenon, we conducted a preliminary project, which demonstrated that there are approximately 250 patients with active TB admitted to one urban South African hospital in one month and that almost half of them are infected with HIV. One quarter of them died while in hospital. They were young people with an average of 32 years. We are interested in undertaking clinical trials that will study novel therapies that can be added to the existing antimicrobial regimens in order to reduce the number of people dying from TB. One of these therapies would be the addition of prednisone, an oral steroid, to the standard TB treatment regimen. Steroids have been shown to be useful in TB meningitis and pericarditis in HIV positive and negative patients. However, steroids have never been tested in a formal manner in HIV patients with pulmonary TB. We have chosen to do our research in South Africa since the numbers of patients needed to design a clinical trial such as the one presented can only be found in such an environment. Prednisone is cheap, easily obtainable and thus a sustainable intervention in developing countries. The impact of the research would affect not only the international community including Canada but would certainly have a lasting sustainable effect on the local community in Pietermaritzburg, South Africa in addition to the rest of the world.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Ottawa Hospital - General Campus | Completed |
Ottawa, Ontario, Canada, K1H 8L6 | |
South Africa, KwaZulu Natal | |
Erendale Hospital | Recruiting |
Pietermaritzburg, KwaZulu Natal, South Africa | |
Contact: Douglas Wilson, MBChB, +27 (0) 33 395 4146 wilsond1@ukzn.ac.za | |
Principal Investigator: Douglas Wilson, MBChB, | |
Sub-Investigator: Gonzalo Alvarez, MD, FCCP |
Study Chair: | Gonzalo Alvarez, MD | Ottawa Health Research Institute |
Study ID Numbers: | 2006301-01H |
Study First Received: | December 19, 2006 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00414414 |
Health Authority: | South Africa: Medicines Control Council; Canada: Health Canada |
TB Tuberculosis HIV Co-infection Steroid |
Prednisone oral corticosteroids TB Treatment South Africa |
Bacterial Infections Prednisone Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Gram-Positive Bacterial Infections |
HIV Infections Tuberculosis, pulmonary Tuberculosis, Pulmonary Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections |
Anti-Inflammatory Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Infection Glucocorticoids Hormones Actinomycetales Infections Pharmacologic Actions Therapeutic Uses Lentivirus Infections |