PER-081-12已完成未知

TRIPLE BLIND, RANDOMIZED, DOSE-RANGING TRIAL OF HIGH-DOSE RIFAMPIN IN PATIENTS WITH NEW, SMEAR-POSITIVE TB (HIGH DOSE RIFAMPIN OF HIRIF STUDY)

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 0 人开始时间: 2013年2月5日最近更新: 2023年9月4日

试验速览

暂无简介。

•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

•1. BODY WEIGHT <30 KG.
•2. PRIOR TREATMENT WITH MULTIDRUG ANTI-TB THERAPY.
•3. RESISTANCE ON HAIN TO INH AND/OR RIF. THESE PATIENTS WILL BE TREATED ACCORDING TO LOCAL PROGRAMMATIC GUIDELINES.
•4. CENTRAL NERVOUS SYSTEM OR MILIARY TB.
•5. CLINICAL OR RADIOLOGICAL SIGNS SUGGESTIVE OF PERICARDIAL OR PLEURAL INVOLVEMENT.
•6. PRESENCE OF SIGNIFICANT HEMOPTYSIS. PATIENTS WHO COUGH UP FRANK BLOOD (MORE THAN BLOOD-STREAKED SPUTUM) WILL NOT BE ELIGIBLE FOR ENROLLMENT.
•7. KNOWN INTOLERANCE TO ANY OF THE STUDY DRUGS. USE OF CONCOMITANT DRUGS THAT INTERFERE WITH THE PHARMACOKINETICS OF ANTI-TB DRUGS, USE OF CONCOMITANT HEPATOTOXIC DRUGS (OTHER THAN COMPANION STUDY DRUGS). SEE TABLE 1. DRUG-DRUG INTERACTIONS WITH RIF (LIKELY IN HIRIF SETTING) REQUIRING CHANGE OF MEDICATION.
•8. HISTORY OF LIVER DISEASE.
•9. UNCONTROLLED CONDITION THAT MIGHT INTERFERE WITH DRUG ABSORPTION, DISTRIBUTION, METABOLISM OR EXCRETION (I.E. CHRONIC GASTRO-INTESTINAL DISEASE, RENAL INSUFFICIENCY DEFINED BY CREATININE CLEARANCE <60ML/MIN).
•10. UNCONTROLLED DIABETES MELLITUS (HBALC >7.5%).

发起方

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,