None listed
Conditions
Interventions
SUBJECTS CAN BE ANTIRETROVIRAL NAÏVE OR EXPERIENCED (WITHOUT PRIOR EXPOSURE TO ATV), TREATMENT EXPERIENCED SUBJECTS ARE DEFINED BY A PREVIOUS EXPOSURE TO ANTIRETROVIRAL DRUGS (ARVS) THROUGH EITHER PRI
1 ARVS AS PART OF A PREVENTION OF MOTHER TO CHILD TRANSMISSION (PMTCT) PROGRAM (IN ACCORDANCE WITH MULTIPLE GUIDELINES: WHO, DHHS, AND SOUTH AFRICA PMTCT GUIDELINES). FOR THE PURPOSES OF THIS TRIAL, S
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT A) INFORMED CONSENT FROM A PARENT/LEGAL GUARDIAN MUST BE OBTAINED PRIOR TO SCREENING. MINORS WHO ARE JUDGED TO BE OF AN AGE OF REASON MUST ALSO GIVE THEIR WRITTEN ASSENT WHERE REQUIRED BY LOCAL REGULATIONS (SEE SECTION 2.3). 2) TARGET POPULATION A) ANTIRETROVIRAL NAIVE WITH A DETECTABLE VIRAL LOAD ≥ 1000 COPIES/ML OR TREATMENT-EXPERIENCED SUBJECTS WITH A DETECTABLE VIRAL LOAD ≥ 400 COPIES/ML. TREATMENT EXPERIENCED SUBJECTS ARE DEFINED BY A PREVIOUS EXPOSURE TO ANTIRETROVIRAL DRUGS (ARVS) THROUGH EITHER PRIOR TREATMENT FOR THEIR HIV DISEASE OR THROUGH A POST-NATAL TREATMENT WITH ≥ 1 ARVS FOR THE PREVENTION OF MOTHER TO CHILD TRANSMISSION (PMTCT). FOR THE PURPOSES OF THIS STUDY, SUBJECTS EXPOSED TO ARVS IN UTERO OR INTRA-PARTUM ARE ELIGIBLE FOR THE STUDY, BUT WILL BE CONSIDERED `TREATMENT NAIVE´. B) CONFIRMED HIV-1 INFECTION DIAGNOSED BY POSITIVE VIROLOGIC TEST RESULTS ON 2 SEPARATE OCCASIONS BY ANY OF THE FOLLOWING: I) HIV DNA PCR. A PREVIOUS DETECTABLE HIV RNA WITH VALUES ≥ 1000 COPIES/ML WILL BE CONSIDERED EVIDENCE OF INFECTION.
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE EXCEPTIONS A) TREATMENT EXPERIENCED SUBJECTS WHO RECEIVED ATV OR ATV/RTV AT ANY TIME PRIOR TO STUDY ENROLLMENT WILL NOT BE ALLOWED IN THE STUDY. B) ANTIRETROVIRAL-NAIVE OR EXPERIENCED HIV-1 INFECTED SUBJECTS WITH CONTRAINDICATION TO STUDY MEDICATIONS. C) SUBJECTS WITH GENOTYPIC RESISTANCE AT SCREENING TO ATV OR EITHER COMPONENT OF THE LOCAL NRTI BACKBONE BASED UPON THE FOLLOWING CRITERIA: I) ANY MAJOR MUTATIONS: 150L, I84V, N88S. II) ≥ 2 OF THE FOLLOWING MINOR OR CROSS RESISTANT MUTATIONS: (1) M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I D) HISTORY OF PSYCHIATRIC OR COGNITIVE/DEVELOPMENTAL IMPAIRMENT THAT COULD COMPROMISE SUBJECT SAFETY OR THE ABILITY OF THE SUBJECT TO COMPLY WITH THE PROTOCOL. 2) MEDICAL HISTORY AND CONCURRENT DISEASES A) ANY ACTIVE CDC CATEGORY C CLINICAL CONDITION. B) COINFECTION WITH EITHER HBV OR HCV I) COINFECTION WITH HBV AS DOCUMENTED BY THE PRESENCE OF HBSAG II) COINFECTION WITH HCV AS DOCUMENTED BY A POSITIVE ANTI-HCV ANTIBODY CONFIRMED BY HCV RNA PCR C) DOCUMENTED CARDIAC CONDUCTION ABNORMALITY(IES) OR SIGNIFICANT CARDIAC DYSFUNCTION, OR A HISTORY OF SYNCOPE.
Countries
Argentina, Brazil, Chile, Mexico, Peru, Russian Federation, South Africa, United States
Contacts
Public ContactSTELA LOPEZ
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed