A study to evaluate the effect of two types of treatment regimen in children with HIV infectio

Phase 1

Conditions: Human Immunodeficiency Virus (HIV-1) Infections
MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-001402-28-GB

Lead Sponsor: Gilead Sciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

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
Participants enrolled after the implementation of Amendment 8:
Virologically suppressed = 3 months preceding the Screening visit: HIV-
1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA
level according to the local assay being used if the limit of detection is =
50 copies/mL)
Viremic: HIV-1 RNA = 50 copies/mL and on a stable regimen
For virologically suppressed subjects, unconfirmed virologic elevations
of = 50 copies/mL (transient detectable viremia, or blip) prior to
screening are acceptable. If the lower limit of detection of the local HIV-
1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1
RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA
tests.

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

Exclusion Criteria

1) Screening CD4 cell count < 200 cells/mm3

2) An acquired immunodeficiency syndrome (AIDS)-defining condition
with onset within 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. Subjects with positive HCV antibody, and
without detectable HCV RNA are permitted to enroll

8) Positive Hepatitis B (HBV) surface antigen or other evidence of active
HBV infection. Note: Subjects with positive HBV surface antibody, and no
evidence of active HBV infection are permitted to enroll

9) Subjects 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 subject 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) Subjects 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. Subjects 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 subjects

14) Current alcohol or substance abuse judged by the Investigator to
potentially interfere with subject 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 following medications (Table 4-1)
must be discontinued for:
-Drug Class - Agents Disallowed:
-Acid Reducing Agents (H2-receptor antagonists [H2RAs] and Proton
Pump Inhibitors [PPIs]) - H2-receptor antagonists and Proton pump
inhibitors
should not be used in patients less than 6 years of age, and/or less than
40 kg receiving ATV
-Alpha Adrenergic Receptor Antagonists - Alfuzosin
-Antibacterials - Telithromycin
-Anticonvulsants - Phenobarbital, Phenytoin, Carbamazepine,
Oxcarbazepine
-Antifungals - Voriconazole
-Antihistamines - Astemizole, Terfenadine

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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