None listed
Conditions
Interventions
PARTICIPANTS FROM RLS WHO PRESENT WITH ADVANCED HIV DISEASE AND WILL BE INIATING ART BUT ARE WITHOUT EVIDENCE OF PROBABLE OR CONFIRMED TB ACCORDING TO CRITERIA IN THE CURRENT ACTG DIAGNOSIS APPENDIX (
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR HIV ENZYME OR CHEMILUMINESCENCE IMMUNOASSAY (E/CIA) TEST KIT AT ANY TIME PRIOR TO STUDY ENTRY, AND CONFIRMED BY A LICENSED WESTERN BLOT OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN THE INITIAL RAPID HIV 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 TEST (e.g., 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 T 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 3 DAYS FOLLOWING RANDOMIZATION.
Exclusion criteria
Exclusion criteria: 4.2.1 WITHIN 30 DAYS PRIOR TO THE STUDY ENTRY AND FOLLOWING COMPLETION OF STUDY-SPECIFIC SCREEING ALGORITHM (SEE SECTION 4.3.6), PRESENCE OF ANY CONFIRMED OR PROBABLE TB BASED ON CRITERIA LISTED IN THE CURRENT ACTG DIAGNOSIS APPENDIX, WHICH IS IDENTIFIED ON THE CRF. 4.2.2 USE OF SINGLE-DOSE NVP FOR PREVENTION OF MOTHER-TO-CHILD TRANSMISSION (pMTCT) WHITIN 24 MONTHS PRIOR TO STUDY ENTRY. NOTE: COMBINATION ANTIRETROVIRALS (ARVs) TAKEN FOR ANY LENGTH OF TIME DURING PREGNANCY FOR pMTCT IS NOT EXCCLUSIONARY. 4.2.3 USE OF PROHIBITED MEDICATIONS (SEE LIST IN 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.
Countries
Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Tanzania, Zimbabwe
Outcome results
None listed