A 5273 : MULTICENTER STUDY OF OPTIONS FOR SECOND-LINE EFFECTIVE COMBINATION THERAPY (SELECT)
- Registration Number
- PER-026-11
- Lead Sponsor
- INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 9
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 ANTIGEN, PLASMA HIV-1 RNA VIRAL LOAD.
NOTE: FOR SITES LOCATED IN COUNTRIES OTHER THAN THE UNITED STATES, THE TERM LICENSED REFERS TO A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THAT COUNTRY AND VALIDATED INTERNALLY.
WHO AND CDC (U.S. CENTERS FOR DISEASE AND PREVENTION) 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.
4.1.2 CONFIRMATION OF FIRST-LINE VIROLOGIC FAILURE
FAILURE OF THE FIRST-LINE REGIMEN IS DEFINED AS TWO CONSECUTIVE MEASUREMENTS OF PLASMA HIV-1 RNA ≥ 1,000 COPIES/ML OBTAINED AT LEAST ONE WEEK APART WHILE ON AN INITIAL NNRTI-BASED REGIMEN.
4.2.1 USE OF ANY INMUNOMODULATOR, HIV VACCINE OR OTHER INVESTIGATIONAL THERAPY WITHIN 45 DAYS PRIOR TO STUDY ENTRY, WITH THE EXCEPTION OF A TAPERING COURSE OF CORTICOSTEROIDS AS ACUTE THERAPY FOR PNEUMOCYSTIS JIROVECI PNEUMONIA (PCP) OR ACUTE ASTHMA/CHRONIC OBSTRUCTIVE PULMONARY DISEASE FLARE AND/OR PREDNISONE AT A DAILY DOSE OF ≤10 MG (PHYSIOLOGIC REPLACEMENT DOSE).
4.2.2 IF THE POTENTIAL PARTICIPANT HAS HAD RESISTANCE TESTING, EVIDENCE OF BROAD NRTI CROSS-RESISTANCE THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD NOT ALLOW SELECTION OF AN EFFECTIVE NRTI COMBINATION IF THE PARTICIPANT WERE RANDOMIZED TO THE LPV/R + BEST AVAILABLE NRTIs ARM.
NOTE: RESISTANCE TESTING IS NOT REQUIRED FOR STUDY PARTICIPATION.
4.2.3 PRIOR EXPOSURE TO A PI.
4.2.4 KNOWN HISTORY OF CONGENITAL LONG QT SYNDROME, HYPOKALEMIA, OR PLANNED USE OF OTHER DRUGS THAT PROLONG THE QT INTERVAL.
4.2.5 PREGNANCY OR BREAST-FEEDING
4.2.6 KNOWN HISTORY OF CHRONIC HBV INFECTION OR CURRENT HBV INFECTION DEFINED BY THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN SERUM OR PLASMA.
4.2.7 ACTIVE TUBERCULOSIS (TB) REQUERING TREATMENT WITH RIFAMPICIN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method