None listed
Conditions
Interventions
IN ADDITION, A SUBTRIAL COMPRISED OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) POSITIVE PATIENTS WHO WILL BE ON ANTIRETROVIRALS (ARVs) DURING THE TRIAL AND WILL BE RANDOMIZED TO OBR PLUS PLACEBO OR OBR PLUS
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC),
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: . CURRENT DIAGNOSIS OF MDR TB FROM ONE OF THE FOLLOWING METHODS: - FROM A SINGLE SPUTUM SPECIMEN COLLECTED NO MORE THAN 90 DAYS PRIOR TO THE DAY TRIAL ENROLLMENT (DEFINED AS THE DATE THE ICF IS SIGNED AND SCREENING BEGINS), MYCOBACTERIAL CULTURE POSITIVE FOR GROWTH OF MTB WITH DOCUMENTED RESISTANCE TO ISONIAZID AND RIFAMPICIN, OR - FROM A SINGLE SPUTUM SPECIMEN COLLECTED NO MORE THAN 90 DAYS PRIOR TO DATE OF TRIAL ENROLLMENT (DEFINED AS THE DATE THE ICF IS SIGNED AND SCREENING BEGINS), SPUTUM SMEAR POSITIVE FOR ACID FAST BACILLI (AFB) WITH POSITIVE RAPID TESTS FOR ISONIAZID AND RIFAMPICIN RESISTANCE. . FINDINGS ON RECENT CHEST RADIOGRAPH CONSISTENT WITH TB. . ABLE TO PRODUCE SPUTUM FOR MYCOBACTERIAL CULTURE.
Exclusion criteria
Exclusion criteria: . ANY CURRENT SERIOUS CONCOMITANT CONDITIONS OR RENAL IMPAIRMENT CHARACTERIZED BY SERUM CREATININE LEVELS ≥ 1.5 mg/dL OR HEPATIC IMPAIRMENT CHARACTERIZED BY ALANINE AMINOTRANSFERASE (ALT) AND/OR ASPARTATE AMINOTRANSFERASE (AST) LEVELS 3 TIMES THE UPPER LIMIT OF THE LABORATORY REFERENCE RANGE. . CURRENT CLINICALLY RELEVANT ABNORMALITIES IN THE SCREENING ECG INCLUDING CONDUCTION ABNORMALITIES (AV BLOCK) OR CORRECTED QT INTERVAL USING FREDERICIA´S FORMULA (QTcF) INTERVAL OVER 450 msec IN MALE PATIENTS AND 470 msec IN FEMALE PATIENTS. . CURRENT CLINICALLY RELEVANT/SIGNIFICANT CARDIOVASCULAR DISORDER SUCH AS CONGESTIVE HEART FAILURE, VENTRICULAR HYPERTROPHY, CORONARY ARTERY DISEASE, ARRHYTMIA, OR POORLY CONTROLLED HYPERTENSION. . BMI < 16.0 KG/M2. . KARNOFSKY SCORE < 50 %. . ANY DISEASES OR CONDITIONS IN WHICH THE USE OF NITRO-IMIDAZOLES OR NITRO-IMIDAZOLE DERIVATES IS CONTRA-INDICATED. . EVIDENCE OF CURRENTLY ACTIVE CLINICALLY SIGNIFICANT METABOLIC, GASTROINTESTINAL, NEUROLOGICAL, PSYQUIATRIC, OR ENDOCRINE DISEASES (eg, POORLY CONTROLLED DIABETES MELLITUS), CURRENTLY ACTIVE MALIGNANCY, OR OTHER ABNORMALITIES (OTHER THAN THOSE RELATED TO THE INDICATION BEING STUDIED). . PREVIOUS EXPOSURE TO DELAMANID. . EVIDENCE OF EXTENSIVELY-DRUG RESISTANT (XDR) TB BASED ON THE WHO DEFINITION, IE, TB WITH DEMONSTRATED RESISTANCE TO ISIONAZID AND RIFAMPICIN
Countries
Estonia, India, Latvia, Lithuania, Modalvia, Peru, Philippines, South Africa
Contacts
Public ContactEdwin Ramirez
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed