ACTG 5343 Bedaquiline - Delamanid with MBT for MDR

Bedaquiline (BDQ) and delamanid (DLM) are two newly approved anti-TB drugs and are both well tolerated. However, the combined effects of these two drugs have not been studied. Combining these two drugs, together with other anti-TB drugs, may improve outcomes for people with MDR-TB. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BDQ and DLM, alone and in combination, among participants (with or without HIV co-infection) taking multidrug treatment for MDR-TB. Researchers will specifically evaluate the effect of these drugs on the heart.

NExT Trial: Bedaquiline - Linezolid with OBR MDR

Experimental: Interventional treatment 6-9 months

Participants will receive six to nine months of oral:

Linezolid 600mg daily (reduce to 300mg if toxicity occurs), Bedaquiline 400mg for 2 weeks, followed by 200mg three times per week, Levofloxacin 750mg (<50kg) or 1000mg (>50kg) daily, PZA 1000-1750mg (40-50kg) or 1750-2000mg (51-70kg) or 2000-2500mg (71-90kg) daily, Ethionamide 15mg/kg (max 900mg) daily, or high-dose Isoniazid 500mg (40-50kg) or 750mg (51-70kg) or 750-1000mg (71-90kg) daily, or Terizidone 750mg (40-70kg) or 750-1000mg (71-90kg) daily.

Rifapentine

Rifapentine is a cyclopentyl derivative of rifampin. It is a drug in the class rifamycins. The US CDC's Tuberculosis Trials Consoritum (TBTC)'s published results of a 4-month rifapentine-based regimen containing moxifloxacin as noninferior to the standard 6-month regimen in the treatment of tuberculosis. 

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