A study to evaluate the effect of two types of treatment regimen in children with HIV infectio
- Conditions
- Human Immunodeficiency Virus (HIV-1) InfectionsMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-001402-28-Outside-EU/EEA
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
1) Age 3 to < 18 years (according to requirements of enrolling Cohort)
2) Participants able to provide written assent if they have the ability to read and write (if applicable per their local institutional guidelines and local country regulations)
3) Parent or legal guardian able to provide written informed consent prior to any screening evaluations, and willing to comply with study
requirements
4) A negative serum -HCG pregnancy test is required for female subjects of childbearing potential only
5) Body weight at screening is as follows:
Cohort 1: 12 years to <18 years, = 25 kg
Cohort 2: 6 years to <12 years, = 25 kg to < 35 kg
Cohort 3: = 3 years, = 14 kg to < 25 kg
6) Adequate renal function: Estimated Glomerular Filtration Rate (eGFR)
= 90 mL/min/1.73 m2 using the Schwartz Formula:
Schwartz Formula (mL/min/1.73 m2) = k x L/SCr (k is a proportionality constant, L is height in centimeters (cm) and SCr is serum creatinine (mg/dL). The value of k is 0.55 for children (= 2 to < 12 years old) and adolescent girls (= 12 years old) and 0.70 for adolescent boys (= 12 years old).
7) Male and female subjects of childbearing potential, or who reach
childbearing potential during study participation, must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period. Pre-pubertal females (Tanner stages 1 and 2) are not considered to be of childbearing potential, unless onset of menarche has occurred.
8) Adequate hematologic function defined as:
a) Absolute neutrophil count = 500 cells/mm3 (Subjects with neutrophil count of < 500/mm3 documented at least twice within 6 months of screening, and whom, according to the investigator, have no evidence of immunosuppression associated with low neutrophil count, can enroll in the study contingent upon approval from the Gilead study Medical Monitor)
b) Hemoglobin > 8.5 g/dL
c) Platelets = 50,000/mm3
9) Adequate hepatic function defined as:
a) Transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
b) Total bilirubin = 1.5 mg/dL or a normal direct bilirubin
10) Stable antiretroviral regimen for a minimum of 3 months prior to the screening visit.
11) Documented plasma HIV-1 RNA for = 3 months preceding the
Screening visit
12) Must be willing and able to comply with all study requirements
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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
1) Screening CD4+ cell count < 200 cells/mm3
2) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
3) Life expectancy of < 1 year
4) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening
5) Evidence of active pulmonary or extra-pulmonary tuberculosis (TB) disease, within 3 months of the Screening visit
6) Anticipated requirement for rifamycin treatment while participating in the study Note: prophylactic isoniazid therapy for latent TB is allowed
7) Active HCV infection. Participants with positive HCV antibody, and without detectable HCV RNA are permitted to enroll
8) Hepatitis B (HBV) surface antigen (HBsAg) positive or other evidence of active HBV infection. Note: Participants with positive HBV surface antibody, and no evidence of active HBV infection are permitted to enroll
9) Participants with clinically significant abnormal ECGs
10) Have any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with participant treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including ulcers), vascular, metabolic (including thyroid disorders and adrenal disease), immunodeficiency disorders, active infection, or malignancies that are clinically significant or require treatment within 30 days prior to Day 1
11) Participants experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
12) A history of, or ongoing, malignancies other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Participants with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1, and are not anticipated to require systemic therapy during the study
13) Pregnant or lactating participants
14) Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance
15) A history of significant drug sensitivity or drug allergy
16) Known hypersensitivity to the investigational medicinal product (IMP), its metabolites, or formulation excipient
17) Have previously participated in a clinical trial involving administration of any investigational agent within 30 days prior to Day 1
18) Participation in any other clinical trial, including observational studies, without prior approval from sponsor is prohibited while participating in this trial
19) Participants receiving ongoing therapy with any medication that is not to be taken with COBI, F/TAF, a component of the current antiretroviral regimen, or drugs not to be used with ritonavir (refer to prescribing information for drugs used as part of the antiretroviral regimen). Administration of any of the disallowed medications as described in the protocol must be discontinued for:
- Participants enrolled prior to implementation of Amendment 7: at least 21 days prior to the Day 1 visit and for the duration of the study
- Participants enrolled after the implementation of Amendment 7: at least 30 days prior to the Day 1 visit and for the duration of the study
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