None listed
Conditions
Interventions
RANDOMIZATION WILL BE 1:1. PARTICIPANTS WILL BE STRATIFIED BASED ON (1) CD4+ CELL COUNT AT ENTRY ( 250 cells/mm³) and (2) ART USE AT ENTRY (YES/NO). EACH PARTICIPANT WILL BE FOLLOWED FOR 3 YEARS (156
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: 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. NOTE: THE TERM LICENSED REFERES TO A US FOOD AND DRUG ADMINISTRATION (FDA)- APPROVED KIT WHICH IS REQUIRED FOR ALL IND STUDIES, OR FOR SITES LOCATED IN COUNTRIES OTHER THAN THE US, A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THAT COUNTRY AND VALIDATED INTERNALLY. NON-U.S. SITES ARE ENCOURAGED TO FDA-APPROVED METHODS FOR IND STUDIES. WHO AND 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 COFIRED BY EITHER ANOTHER TYPE OF RAPID ASSAY OR AN E/CIA THAT IS BASED ON A DIFFERENT ANTIGEN PREPARATION AND/OR DIFFERENT TEST PRINCIPLE (e.g., INDIRECT VERSUS COMPETITIVE), OR A WESTERN BLOT OR A PLASMA HIV-1 RNA VIRAL LOAD.
Exclusion criteria
Exclusion criteria: 4.2.1 TREATMENT FOR ACTIVE OR LATENT TB (PULMONARY OR EXTRAPULMONARY) WITHIN 2 YEARS PRIOR TO STUDY ENTRY OR, AT SCREENING, PRESENCE OF ANY CONFIRMED OR PROBABLE TB BASED ON CRITERIA LISTED IN THE CURRENT ACTG DIAGNOSIS APPENDIX. 4.2.2 HISTORY OF MULTI-DRUG RESISTANT (MDR) OR EXTENSIVELY-DRUG RESISTANT (XDR) TB AT ANY TIME PRIOR TO STUDY ENTRY. 4.2.3 KNOWN EXPOSURE TO MDR OR XDR TB (e.g., HOUSEHOLD MEMBER OF A PERSON WITH MDR OR XDR TB) AT ANY TIME PRIOR TO STUDY ENTRY. 4.2.4 TREATMENT FOR > 14 CONSECUTIVE DAYS WITH A RIFAMPICIN OR > 30 CONSECUTIVE DAYS WITH INH AT ANY TIME DURING THE 2 YEARS PRIOR TO ENROLLMENT. 4.2.5 FOR PARTICIPANTS TAKING ART, ONLY NRTI- AND NNRTI-BASED REGIMENS WILL BE ALLOWED AT STUDY ENTRY AND DURING THE FIRST 4 WEEKS OF STUDY TREATMENT WITH RTP. TREATMENT WIH ANY OTHER ART REGIMEN (e.g., PI-BASED ON, RALTEGRAVIR-CONTAINING) AT STUDY ENTRY OR PLANS TO INITIATE SUCH A REGIMN DUING THE FIRST 4 WEEKS OF STUDY TREATMENT IS EXCLUSIONARY. 4.2.6 HISTORY OF LIVER CIRRHOSIS AT ANY TIME PRIOR TO STUDY ENTRY. 4.2.7 EVIDENCE OF ACUTE HEPATITIS, SUCH AS ABDOMINAL PAIN, JAUNDICE, DARK URINE, AND/OR LIGHT STOOLS WITHIN 90 DAYS PRIOR TO ENTRY.
Countries
Botswana, Brazil, Haiti, India, Malawi, Peru, Puerto Rico, South Africa, Thailand, United States, Zambia, Zimbabwe
Contacts
Public ContactFanny Leticia Garcia
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed