REDUCING EARLY MORTALITY AND EARLY MORBIDITY BY EMPIRIC TUBERCULOSIS TREATMENT REGIMENS (REMEMBER)

Not Applicable

• Registration Number: PER-030-11
• Lead Sponsor: El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR HIV ENZYME OR CHEMILUMINESCENCE IMMUNOASSAY FOR HIV (E/CIA) TEST KIT AT ANY TIME PRIOR TO STUDY ENTRY AND CONFIRMED BY A KICENSED WESTERN BLOT OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN THE INITIAL RAPID HIV TEST AND/OR E/CIA, OR BY HIV-1 ANTIGEN, PLASMA HIV-1 RNA VIRAL LOAD.
THE WHO AND THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES MANDATE THAT CONFIRMATION OF THE INITIAL TEST RESULT MUST USE A TEST THAT IS DIFFERENT FROM THE ONE USED FOR THE INITIAL ASSESSMENT. A REACTIVE INITIAL RAPID TEST SHOULD BE CONFIRMED BY EITHER ANOTHER TYPE OF RAPID ASSAY OR AN E/CIA THAT IS BASED ON A DIFFERENT ANTIGEN PREPARATION AND/OR DIFFERENT TEST PRINCIPLE (eg, INDIRECT VERSUS COMPETITIVE), OR A WESTERN BLOT OR A PLASMA HIV-1 RNA VIRAL LOAD.
NOTE: THE TERM LICENSED REFERS TO A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THE COUNTRY IN WHICH IT IS USED AND HAS BEEN VALIDATED INTERNALLY.
4.1.2 WILLINGNESS TO START EFAVIRENZ-BASED ART AS SOON AS POSSIBLE AND WITHIN NO MORE THAN THREE DAYS FOLLOWING RANDOMIZATION.
4.1.3 CD4 + CELL COUNT <50 CELLS / MM ³ OBTAINED WITHIN 45 DAYS PRIOR TO STUDY ENTRY AT ANY LABORATORY THAT HAS A CLIA CERTIFICATION OR ITS EQUIVALENT.

Exclusion Criteria

4.2.1 WITHIN 30 DAYS PRIOR TO THE STUDY OF INCOME AND AFTER COMPLETING THE SPECIFIC DETECTION ALGORITHM STUDY (SEE SECTION 4.3.6), THE PRESENCE OF ANY CONFIRMED OR PROBABLE TB BASED CRITERIA LISTED IN THE APPENDIX ACTG CURRENT DIAGNOSIS, WHICH IS IDENTIFIED IN THE CRF.
4.2.2 USE OF SINGLE DOSE NVP FOR PREVENTION OF MOTHER-TO-CHILD TRANSMISSION (pMTCT) WITHIN 24 MONTHS PRIOR TO STUDY ENTRY.
NOTE: COMBINATION ANTIRETROVIRALS (ARVs) TAKEN FOR ANY LENGTH DURING PREGNANCY FOR pMTCT EXCLUSIONARY.
4.2.3 USE OF PROHIBITED MEDICATIONS (SEE LIST IN THE A5274/REMEMBER MOPS, SECTION 3.2.1) WITHIN 30 DAYS PRIOR TO STUDY ENTRY.
4.2.4 KNOWN ALLERGY / SENSITIVITY OR ANY HYPERSENSITIVITY TO COMPONENTS OF STUDY-REQUIRED ART OR TB TREATMENT.
4.2.5 CURRENT RECEIPT OF TREATMENT FOR ACTIVE TB OR RECEIPT OF > 14 DAYS CUMULATIVE TREATMENT FOR ACTIVE TB WITHIN 96 WEEKS PRIOR TO STUDY ENTRY.
4.2.6 RECEIPT OF > 30 DAYS CUMULATIVE OF INH PROPHYLAXIS WITHIN 48 WEEKS PRIOR TO STUDY ENTRY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified