PER-118-11未知未知

MANAGEMENT USING THE LASTEST THECNOLOGIES IN RESOURCE-LIMITED SETTINGS TO OPTIMIZE COMBINATION THERAPY AFTER VIRAL FAILURE (MULTI-OCTAVE)

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 32 人开始时间: 2012年3月26日最近更新: 2023年9月4日

试验速览

暂无简介。

•INCLUSION CRITERIA FOR STEP 1
•4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR AN IMMUNOLOGICAL 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 VL.
•NOTE: THE TERM LICENSED REFERS TO AN FDA- APPROVED KIT. NON-US SITES ARE ENCOURAGED TO USE FDA-APPROVED METHODS. IF AN FDA-APPROVED KIT IS NOT AVAILABLE, THEN SITES MUST USE A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY A SUPERVISOR INSTITUTION WITHIN THAT COUNTRY AND VALIDATED INTERNALLY.
•WHO AND CDC (CENTERS FOR DISEASE CONTROL AND PREVENTION) GUIDELINES ORDER 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 VL.

•EXCLUSION CRITERIA FOR STEP 1
•4.2.1 PREGNANCY OR BREAST-FEEDING
•4.2.2 KNOWN ALLERGY/SENSITIVITY OR ANY HYPERSENSITIVITY TO COMPONENTS OF STUDY DRUGS OR THEIR FORMULATION.
•4.2.3 ACTIVE DRUG OR ALCOHOL USE OR DEPENDENCE THAT, IN THE OPINION OF THE SITE INVESTIGATOR, WOULD INTERFERE WITH ADHERENCE TO STUDY REQUIREMENTS.
•4.2.4 SERIOUS ILLNESS REQUIRING SYSTEMIC TREATMENT AND/OR HOSPITALIZATION UNTIL CANDIDATE EITHER COMPLETES THERAPY OR TO BE CLINICALLY STABLE ON THERAPY, IN THE OPINION OF THE SITE INVESTIGATOR, FOR AT LEAST 7 DAYS PRIOR TO STUDY ENTRY.
•4.2.5 CONCURRENT ILLNESS OR CONDITION THAT WOULD COMPROMISE THE ABILITY TO TAKE STUDY MEDICATION, FOLLOW THE PROTOCOL, OR THAT WOULD MAKE PARTICIPATION NOT BE OF INTEREST FOR THE PARTICIPANT.
•4.2.6 REQUIREMENT FOR TAKING ANY OF THE PROHIBITED MEDICATIONS WITH THE SELECTED ART STUDY REGIMEN, OR WITHIN 14 DAYS PRIOR TO STUDY ENTRY (SEE SECTION 5.4.2).
•4.2.7 ACTIVE TUBERCULOSIS (TB) OR RIFAMPIN EXPOSURE LESS THAN 2 WEEKS PRIOR TO STUDY ENTRY.

发起方

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