Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
HIV-1 infected male and female individuals 4 weeks (gestational age of at least 44 weeks) to less than 18 years of age at Baseline.
Individuals are able to provide written assent if they have the ability to read and write.
Parent or legal guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements.
Body weight at screening greater than 5kg, 10.6kg, or 15kg dependent upon age cohort
Adequate renal function
Adequate hematologic function
Hepatic transaminases (AST and ALT) less than or equal to 5 x upper limit of normal (ULN)
Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin
Negative serum pregnancy test
Individuals with evidence of suppressed viremia
Individuals failing a current antiretroviral regimen at study entry
Male and female individuals of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse of reproductive potential throughout the study period and for 30 days following the last dose of study drug
Must be willing and able to comply with all study requirements.
You may not be if
Individuals with CD4+ cell counts at Screening of less than 50, 75, or 200 cells/mm3 dependent on age cohort
An AIDS defining condition with onset within 30 days prior to screening
Life expectancy of less than 1 year
For Individuals with HIV-1 RNA greater than 1,000 copies/mL at screening, prior treatment of any duration with an integrase strand transfer inhibitor.
An ongoing serious infection requiring systemic antibiotic therapy at the time of screening.
Evidence of active pulmonary or extra-pulmonary tuberculosis disease
Anticipated requirement for rifamycin treatment while participating in the study.
Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with Individual's treatment, assessment, or compliance with the protocol.
Individuals experiencing decompensated cirrhosis
A history of or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
Pregnant or lactating females.
Current alcohol or substance abuse judged by the Investigator to potentially interfere with individual's compliance.
Have history of significant drug sensitivity or drug allergy.
Known hypersensitivity to the study drug, the metabolites, or formulation excipients.
Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial.
Individuals receiving ongoing therapy with any medication that is not to be taken with EVG or a component of the BR, including drugs not to be used with ritonavir
Clareo Health | Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
