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Tuberculosis Trials Consortium (TBTC)

Dr Wafaa El-Sadr is site Principal Investigator for the Tuberculosis Treatment Consortium and a member of the Core Science Group for the Consortium. The Charles P. Felton National TB Center site for the CDC-funded TBTC has participated in recruiting and following-up close to 50 patients enrolled in studies evaluating various treatment regimens for TB disease, including studies of treatment of HIV-related TB, of INH-resistant TB, and of various doses of rifapentine. Additionally, we participated in several pharmacokinetic studies evaluating the relationship between TB drug levels and treatment outcomes, studies of the drug-drug interactions between TB medications and antiretroviral medications, and nucleic acid amplification tests to predict relapse of TB and monitor effectiveness of treatment. Moreover, we are anticipating that we will enroll close to 300 patients in a study to evaluate the effectiveness and tolerability of weekly INH/rifapentine for 3 months versus daily INH for 9 months for the treatment of LTBI.  Additionally, Dr El-Sadr has started a sub-site in Durban, South Africa. In the short time since its inception, the site has recruited 36 patients in Study 27 and 15 patients in NAA.

Study 23A
Substudy to evaluate isoniazid and rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving antiretroviral therapy.

Study 26
Trial of short-course treatment of latent TB infection among contacts of active cases, probably using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month therapy with isoniazid. Aims to enroll 7,700 persons.

Study 27

Compare the safety and microbiological activity of a moxifloxacin-containing regimen (isoniazid, rifampin, pyrazinamide, moxifloxacin [HRZMoxi]) to a control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis.

Study 28

Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment


A Pilot Study to Evaluate Nucleic Acid Amplification Tests to Predict Relapse of Tuberculosis and to Monitor the Effectiveness of Treatment