A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV-1) Infections; MedDRA version: 19.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-002673-11-Outside-EU/EEA
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-15
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Currently on a stable antiretroviral regimen for = 6 consecutive months
• 12 years to < 18 years of age
• Weight = 35kg (77 lbs.)
• Subjects able to give written assent prior to any screening evaluations
• Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
• Plasma HIV-1 RNA levels < 50 copies/mL for = 6 months preceding the screening visit (measured at least twice using the same assay) and not experienced two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year.
• CD4+ cell count > 100 cells/µL
• No documented history of resistance to EVG, FTC, 3TC or TFV including, but not limited to, the presence of reverse transcriptase mutations K65R, K70E, M184V/I, or 3 or more thymidine analog-associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R).
• Adequate renal function: Estimated glomerular filtration rate = 90 mL/min/1.73 m2
• Clinically normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
• Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
• No evidence of current HBV infection
• No evidence of current HCV infection
• For subjects on all agents except ATV, total bilirubin or normal direct bilirubin = 1.5 mg/dL
• For all subjects on ATV, total bilirubin or normal direct bilirubin = 3.0 mg/dL
• Adequate hematologic function (absolute neutrophil count = 500/mm3; platelets = 50,000/mm3; hemoglobin = 8.5 g/dL)
• Negative serum pregnancy test for all female subjects
• Females of childbearing potential (as defined in Appendix 5) must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from Screening throughout the duration of study treatment and for 30 days following discontinuation of investigational medicinal product.
• Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
• Male subjects must agree to utilize highly effective contraception methods during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from Baseline throughout the study period and for 30 days following discontinuation of investigational medicinal product.
• Male subjects must refrain from sperm donation from Day -1 through completion of the study and continuing for at least 30 days from the date of last dose of study drug.
• Able to swallow oral tablets
• Must be willing and able to comply with all study requirements
• Life expectancy > 1 year
• Lactating females must agree to discontinue nursing before initiating study drug

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

• A new AIDS-defining condition diagnosed within the 30 days prior to Screening
• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
• Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study. Note: prophylactic INH therapy for latent TB treatment is allowed.
• Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
• Pregnant or lactating subjects
• Have an implanted defibrillator or pacemaker
• 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.
• Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
• Have history of significant drug sensitivity or drug allergy.
• Known hypersensitivity to the study drugs, the metabolites or formulation excipients
• Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study Screening or expected to receive these agents during the study
• A history of malignancy within the past 5 years (prior to Screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study.
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
• 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 (including observational trials) without prior approval from sponsor is prohibited while participating in this trial.
• Subjects receiving ongoing therapy with any of the medications specified in protocol section 4.3, including drugs not to be used with EVG, COBI, FTC, TDF and TAF

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified