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

Not Applicable

Completed

• Registration Number: PER-081-12
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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

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%).

Study & Design

• Study Type: Interventional
• Study Design: Not specified