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

Tuberculosis

Meloxicam 7.5mg daily for 8 weeks

Stellenbosch University Tygerberg Hospital

TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial

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

Prof Jean Nachega

Professor Extraordinary

University of Stellenbosch

University of Pittsburgh

Previously collected tissue samples are analyzed for K-ras mutations; COX-2, phospho-AKT, and VEGF overexpression; microvessel density; association of genomic instability with microsatellite instability and p53 mutations; and methylation status of MLH1, MGMT, and WRN and to identify prognostic biomarkers by LINE-1 hypomethylation, PIK3CA mutation, BRAF mutation, FASN expression, and VDR expression via immunohistochemistry, PCR, RT-PCR, and microarray.

Colorectal Cancer

laboratory biomarker analysis

Brigham and Women's Hospital

Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581

Correlative Science Studies in Colon Cancer a Companion Study to CALGB 9581 and 89803

Using stratified analyses, effect modification by molecular alterations will be assessed. To maintain statistical power, body mass index and physical activity will be categorized into tertiles for the analyses of interactions with tumor molecular alterations. To assess whether the relative effect of an exposure differs according to the presence of the molecular alteration, tests for statistical interaction will be performed by entering into the model the cross-product term of the molecular alteration (as an indicator variable) and the other risk factor for cancer recurrence.

Proper adjustment for multiplicity must be applied.

Will use the Kaplan Meier product-limit estimator.

Weighted Cox proportional hazards regression models will be fit and Wald-type test statistics for the model parameters will be constructed using weighted partial likelihood estimates and robust variance estimates.

Interaction hazard ratios and the Cox model will be used.

It is also planned to establish whether this correlates with response to the camptothecin-related compound irinotecan hydrochloride.

cyclooxygenase/sarkoma

TB-IRIS NSAID Cox-2 Inhibitor Prevention Trial

Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581

The Role of Lymphangiogenesis in Head and Neck Cancer Metastasis

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