None listed
Conditions
Interventions
THE INTERVENTION PHASE OF THIS PROSPECTIVE, RANDOMIZED, TRIPLE-BLINDED TRIAL WILL LAST 8 WEEKS, THE DURATION OF THE STANDARD INTENSIVE PHASE FOR SHORT-COURSE CHEMOTHERAPY FOR TB. DURING THAT TIME, SUB
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. NEWLY DIAGNOSED PULMONARY TB WITH ACID-FAST BACILLI (>=2+) IN A STAINED SPUTUM SMEAR. 2. SUSCEPTIBILITY OF ISOLATE TO INH AND RIF BY HAIN TEST. 3. WILLINGNESS TO UNDERGO HIV TESTING. SEROLOGY NEED NOT BE REPEATED IF NEGATIVE HIV SEROSTATUS WAS DOCUMENTED WITHIN SIX MONTHS PRIOR TO ENROLLMENT OR IF VERIFIABLE POSITIVE SEROSTATUS WAS DOCUMENTED USING A VALIDATED TEST ANY TIME PREVIOUSLY. 4. AGE ≥ 18 YEARS AND <61 YEARS. 5. SIGNED INFORMED CONSENT. 6. NEGATIVE SERUM PREGNANCY TEST (WOMEN OF CHILDBEARING POTENTIAL). 7. WOMEN OF CHILD-BEARING POTENTIAL MUST AGREE TO PRACTICE A DOUBLE-BARRIER METHOD OF BIRTH CONTROL DURING TREATMENT. ADEQUATE CONTRACEPTIVES (CONDOMS AND SPERMICIDE) WILL BE PROVIDED BY THE STUDY TO AVOID PREGNANCY AMONG FEMALE SUBJECTS. 8. KARNOFSKY SCORE OF AT LEAST 50 (REQUIRES CONSIDERABLE ASSISTANCE AND FREQUENT MEDICAL CARE). 9. INTENDS TO REMAIN IN JURISDICTION OF HEALTH CENTER DURING STUDY AND FOLLOW UP. 5.3 SUBJECT
Exclusion criteria
Exclusion criteria: 1. BODY WEIGHT 7.5%).
Countries
Peru, United Kindgdom, United States
Contacts
Public ContactLeonid Wilbert Lecca
Socios En Salud Sucursal Peru
Outcome results
None listed