Trial record 1 of 29 for:    " April 07, 2013":" May 07, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01854775
First received: May 3, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

This study is to confirm the dose and evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment naive adolescents. Antiviral activity will be determined by the achievement of HIV-1 RNA < 50 copies/mL at Weeks 24 and 48.


Condition Intervention Phase
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Drug: E/C/F/TAF
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Plasma pharmacokinetics (PK) parameter of EVG as measured by AUCtau and PK parameter of TAF as measured by AUClast [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    • AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
    • AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration

  • Incidence of treatment-emergent serious adverse events and all treatment-emergent adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Treatment-emergent serious adverse events and adverse events will be summarized.


Secondary Outcome Measures:
  • Percentage of participants with plasma HIV-1 RNA < 50 copies/mL [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of subjects with plasma HIV-1 RNA < 400 copies/mL [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline in plasma log10 HIV-1 RNA (copies/mL) [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count (cells/μL) and percentage [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • PK parameters of EVG as measured by Ctau, Cmax, apparent clearance, and apparent Vz, PK parameters of TAF as measured by Cmax, apparent clearance, and apparent Vz, and PK parameters of FTC, tenofovir (TFV), and COBI as measured by AUCtau, Cmax, and Ctau [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    • Ctau is defined as the observed drug concentration at the end of the dosing interval
    • Cmax is defined as the maximum observed concentration of drug in plasma
    • Vz is defined as the volume of distribution of the drug
    • AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will receive E/C/F/TAF STR once daily with food
Drug: E/C/F/TAF
E/C/F/TAF STR tablets contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF; as 11.2 mg of TAF fumarate)

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. Subjects with screening results that do not meet eligibility criteria will not be allowed to rescreen:

  • 12 years to < 18 years of age at Baseline
  • Weight greater than or equal to 35 kg (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 of > 1,000 copies/mL at Screening (Roche COBAS TaqMan v2.0)
  • CD4+ cell count > 100 cells/microliter
  • Screening genotype report shows sensitivity to EVG, FTC and TFV
  • Adequate renal function
  • Clinically normal ECG
  • Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a Screening visit.
  • Hepatic transaminases less than or equal to 5 x upper limit of normal
  • Total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • No prior use of any approved or experimental anti-HIV-1 drug for any length of time
  • Negative serum pregnancy test
  • Females of childbearing potential 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.
  • Able to swallow oral tablets
  • Must be willing and able to comply with all study requirements
  • Life expectancy > 1 year

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

  • A new AIDS defining condition diagnosed within the 30 days prior to Screening
  • Positive Hepatitis C antibody
  • Positive Hepatitis B surface antigen or other evidence of active hepatitis B virus infection.
  • Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time
  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the Screening visit.
  • Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study.
  • Subjects experiencing decompensated cirrhosis
  • 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.
  • 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 without prior approval from sponsor is prohibited while participating in this trial.
  • Subjects receiving ongoing therapy with any of the medications in the table below, including drugs not to be used with EVG, COBI, FTC, tenofovir disoproxil fumarate (TDF) and TAF; or subjects with any known allergies to the excipients of E/C/F/TAF STR tablets.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854775

Contacts
Contact: Skanda Goudar 650-524-4274 skanda.goudar@gilead.com

Locations
United States, California
Miller's Children Hospital Active, not recruiting
Long Beach, California, United States, 90806
Alta Bates Summit Medical Center Active, not recruiting
Oakland, California, United States, 94609
United States, Colorado
Children's Hospital Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20852
United States, Florida
University of South Florida - Department of Pediatrics Active, not recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-727-4972      
Principal Investigator: Rana Chakraborty, MD         
United States, New York
New York University Active, not recruiting
New York, New York, United States, 10016
SUNY Upstate Medical Center Active, not recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Tennessee
St. Jude Children's Research Hospital Active, not recruiting
Memphis, Tennessee, United States, 38105
Mexico
Hospital Civil de Gualdalajara Fray Antonio Alcalde Withdrawn
Guadalajara, Jalisco, Mexico, 44280
South Africa
Desmond Tutu HIV Foundation Active, not recruiting
Cape Town, South Africa, 7925
University of Stellenbosch Active, not recruiting
Cape Town, South Africa, 7522
Be Part Yoluntu Centre Withdrawn
Cape Town, South Africa, 7646
Mpati Medical Centre Active, not recruiting
Dundee, South Africa, 3000
Gulam Latiff Private Practice Active, not recruiting
Durban, South Africa, 4001
Clinical HIV Research Unit Active, not recruiting
Johannesburg, South Africa, 2092
Rahima Moosa Mother and Child Hopsital Active, not recruiting
Johannesburg, South Africa, 2112
Perinatal HIV Research Unit Active, not recruiting
Soweto, South Africa, 2013
Thailand
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT) Active, not recruiting
Pathumwan, Bangkok, Thailand, 10330
Department of Pediatrics, Faculty of Medicine, Khon Kaen University Active, not recruiting
Muang, Khon Kaen, Thailand, 40002
Queen Savang Vadhana Memorial Hospital Active, not recruiting
Chonburi, Thailand, 20110
Uganda
Joint Clinical Research Centre Recruiting
Lubowa Hill, Kampala, Uganda, PO Box 10005
Contact    +256414201148      
Principal Investigator: Hilda Kizito, MD         
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Sean Bennett, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01854775     History of Changes
Other Study ID Numbers: GS-US-292-0106, 2013-002780-26
Study First Received: May 3, 2013
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Adolescents
HIV-1
HIV
Treatment-naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Tenofovir
Emtricitabine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 25, 2014