A study to investigate the dose, safety and effectiveness of an experimental drug called elvitegravir for the treatment of HIV infection in children and adolescent patients. Patients must have previously received treatment for their HIV infection, and elvitegravir will be added to their current treatment which must include a ritonavir-boosted protease inhibitor.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
Antiretroviral treatment-experienced, HIV-1 infected male and
female subjects 4 weeks (gestational age of at least 44 weeks)
to < 18 years of age
• Body weight at screening as follows:
o Cohort 2 – greater than 15 kg
o Cohort 3 – greater than 10.6 kg
o Cohort 4 – greater than 5 kg
• Part A: Evidence of suppressed viremia or failing a current
antiretroviral regimen as defined below.
• Part B: Evidence of failing a current antiretroviral regimen as
defined below.
Criteria for subjects with evidence of suppressed viremia (Part A
only):
• Plasma HIV-1 RNA concentration (at least 2 consecutive
measurements) at an undetectable level according to the assay
being used for at least 3 months prior to screening, and HIV-1
RNA <50 copies/mL (Roche COBAS TaqMan v2.0) at
screening.
• Stable antiretroviral regimen including one of the following
PI/r for at least 3 months prior to screening: lopinavir/r
(Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or
fosamprenavir/r. Subjects undergoing dose modifications to
their antiretroviral regimen for growth or switching medication
formulations are considered to be on a stable antiretroviral
regimen.
Criteria for subjects failing a current antiretroviral regimen
(Parts A and B):
• HIV-1 RNA >1,000 copies/mL at screening
(Roche COBAS TaqMan v2.0)
• Prior treatment for HIV-1 infection, defined as 6 months of
antiretroviral treatment experience (with the exception of
Cohort 4 where less than 6 months of treatment experience is
acceptable) and at least 1 documented resistance mutation as
defined by current IAS-USA Guidelines. These resistance
mutations must be documented in a historical genotype
report(s), or in the genotype report at screening provided by
Gilead Sciences.
• Stable antiretroviral regimen (or no antiretroviral regimen) for
at least 30 days prior to screening. Subjects undergoing dose
modifications to their antiretroviral regimen for growth or
switching medication formulations are considered to be on a
stable antiretroviral regimen.
• Screening genotype must show full sensitivity to EVG.
• Ability to construct a BR that must contain one of the
following fully active PI/r: lopinavir/r (Kaletra), atazanavir/r,
darunavir/r, tipranavir/r, or fosamprenavir/r. (Fully active is
defined by genotypic analysis.)
• Genotypic sensitivity score (GSS) of at least 2 (including the
fully active PI/r and EVG).
• Adequate renal, hematologic, and hepatic function.
• No opportunistic infection within 30 days of study entry.
Are the trial subjects under 18? yes
Number of subjects for this age range: 86
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
• Subjects with the following CD4+ cell counts:
— For Cohorts 1 and 2: Screening CD4+ cell count
< 50 cells/mm3
— For Cohort 3: Screening CD4+ cell count < 75 cells/mm3
— For Cohort 4: Screening CD4+ cell count < 200 cells/mm3
Evidence of active pulmonary or extra-pulmonary tuberculosis
disease:
— Within 3 months of the Screening visit for all subjects
6 months of age or older
— At any time for subjects younger than 6 months
• An ongoing serious infection requiring systemic antibiotic
therapy at the time of screening
• An acquired immunodeficiency syndrome (AIDS)-defining
condition with onset within 30 days prior to screening
• Life expectancy of < 1 year
• For subjects with HIV-1 RNA >1,000 copies/mL at screening,
prior treatment of any duration with an integrase strand transfer
inhibitor.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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