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TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial

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ClinicalTrials.gov Identifier: NCT02060006
Recruitment Status : Unknown
Verified April 2014 by Prof Jean Nachega, University of Stellenbosch.
Recruitment status was:  Recruiting
First Posted : February 11, 2014
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Prof Jean Nachega, University of Stellenbosch

Tracking Information
First Submitted Date  ICMJE February 7, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2014)
Incidence of TB IRIS [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02060006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2014)
  • Proportion discontinuing Meloxicam due to adverse event [ Time Frame: 6 months ]
  • The proportion of patients in each arm with the following indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III [ Time Frame: 6 months ]
  • The proportion of patients with local or disseminated suppuration/abscess of any site, unscheduled clinic visits, hospitalizations, missed more than a day at work, etc [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial
Official Title  ICMJE A Double-Blind Randomized Placebo Controlled Trial for Prevention of Tuberculosis-Immune Reconstitution Inflammatory Syndrome With Non-Steroid Anti-Inflammatory Drugs (NSAIDs) in HIV-Infected Adults
Brief Summary

Background: Non-Steroid Anti-Inflammatory Drugs (NSAIDs) reduce pain and inflammation by inhibiting cyclooxygenase, an enzyme in the pathway for formation of prostaglandins and thromboxane. Prior studies have proven the role of ibuprofen (an NSAID) in modulating lung injury and decreasing pulmonary damage in cystic fibrosis. While there has been an intense effort by the scientific community to define the best treatment strategies for tuberculosis immune reconstitution inflammatory syndrome (TB-IRIS), to our knowledge there is no available study evaluating preventive strategies using anti-inflammatory agents for TB-IRIS, a highly morbid complication in HIV-infected TB patients initiating antiretroviral therapy (ART).

Design and Methods: We propose to conduct a single center double-blind placebo-controlled randomized trial to investigate the efficacy of daily self-administered Meloxicam (a NSAID) versus placebo for prevention of Tuberculosis associated Immune Reconstitution Inflammatory Syndrome (TB-IRIS). A total of 150 HIV-infected adults who are treated for Tuberculosis for at least 2 weeks and about to initiate HIV treatment at Brewelskloof Hospital, Worcester, and Tygerberg Teaching Hospital, Cape Town, will be randomized to one of the following treatments: Meloxicam 7.5 mg tablet once-a-day, the experimental arm, versus Placebo tablet once-a-day, the control arm, for 8 weeks. All patients will be followed up for 12 months. Primary efficacy outcome: The decrease of the incidence of paradoxical TB IRIS by at least 20%; Primary safety outcome: The proportion of patients who temporarily or permanently discontinue Meloxicam due to any adverse event (e.g. dyspepsia or gastro-intestinal upset). Secondary outcomes are: 1) the proportion of patients in each arm with the following indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III, presence of local or disseminated suppuration/abscess of any site, unscheduled clinic visits, hospitalizations, missed more than a day at work, etc; 2) The incidence of other types of IRIS (e.g. Kaposi Sarcoma or cryptococcal meningitis).

This study will provide important and novel data on the feasibility and efficacy of using a cheap, widely available NSAID used in both developed and developing countries, as a preventive intervention for TB-IRIS that could be quickly put into practice if proven to be effective

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Tuberculosis
Intervention  ICMJE Drug: Meloxicam 7.5mg daily for 8 weeks
Meloxicam 7.5mg daily for 8 weeks
Other Name: Cox-2 Inhibitor
Study Arms  ICMJE
  • Placebo Comparator: Placebo 7.5 mg daily for 8 weeks
    Placebo 7.5 mg once-daily First 8 weeks of ART Only Control arm
  • Experimental: Meloxicam 7.5 mg once-daily
    Meloxicam 7.5mg once-daily for 8 weeks
    Intervention: Drug: Meloxicam 7.5mg daily for 8 weeks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and non-pregnant females age 18 years of age or older
  • Evidence of HIV-1 infection
  • TB treatment (<2 weeks) and initiating EFV-based antiretroviral therapy as per the South African Department of Health Guidelines
  • Living in the study site catchment area and having had a known address for more than 3 months
  • Written informed consent

Exclusion Criteria:

  • History of aspirin sensitivity and allergies to other NSAIDs
  • Current or recent use (<3 months) of aspirin, NSAIDs, or anticoagulants such as warfarin.
  • Current or recent use of corticosteroid therapy
  • History of gastro-intestinal bleeding or peptic ulcer
  • History of cardiovascular thrombotic events (myocardial infarction or stroke), hypertension, or congestive heart failure
  • Severe renal impairment as evidenced by creatinine clearance <50 (Cockcroft- Gault Formula)
  • Severe liver disease (ALT > five times upper limit of normal)
  • Presence of a medical condition likely to result in death within 6 months from start of ART. These conditions include suspected or CNS lymphoma, PMLE and disseminated visceral Kaposi's sarcoma
  • Cognitive disorder(s) that could impair ability to comply with study requirements, as determined by the study physician
  • Karnofsky performance score <60
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060006
Other Study ID Numbers  ICMJE PRO13060453
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Jean Nachega, University of Stellenbosch
Study Sponsor  ICMJE University of Stellenbosch
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE Not Provided
PRS Account University of Stellenbosch
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP