TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons

NCT00463086

Tuberculosis Latent Tuberculosis Infection HIV Infections

COMPLETED NA

Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

NCT03941210

HIV Infection Tuberculosis Infection

UNKNOWN

Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

NCT00000636

HIV Infections Tuberculosis

COMPLETED NA

Gene Expression in HIV and Tuberculosis Co-infection

NCT01611402

Tuberculosis

COMPLETED

Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis

NCT00078247

HIV Infections Tuberculosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo 7.5 mg daily for 8 weeks

Placebo 7.5 mg once-daily First 8 weeks of ART Only Control arm

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Meloxicam 7.5 mg once-daily

Meloxicam 7.5mg once-daily for 8 weeks

Group Type EXPERIMENTAL

Meloxicam 7.5mg daily for 8 weeks

Intervention Type DRUG

Meloxicam 7.5mg daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meloxicam 7.5mg daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cox-2 Inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No