Trial record 1 of 37 for:    " August 07, 2013":" September 06, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01923311
First received: August 9, 2013
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of ritonavir (RTV)-boosted elvitegravir (EVG/r). This study will also evaluate the safety, tolerability, and antiviral activity of elvitegravir (EVG) administered with a background regimen containing a ritonavir-boosted protease inhibitor (PI/r) in HIV-1 infected, antiretroviral (ARV) treatment-experienced pediatric participants.

The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG.


Condition Intervention Phase
Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Drug: EVG
Drug: Background regimen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered With a Background-Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Plasma pharmacokinetics (PK) parameters of EVG as measured by AUCtau and Cmax [ Time Frame: Day 10 ] [ 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)
    • Cmax is defined as the maximum concentration of drug

  • Incidence of treatment-emergent adverse events and laboratory abnormalities [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    The incidence of treatment-emergent adverse events and laboratory abnormalities will be summarized.


Secondary Outcome Measures:
  • PK parameters of EVG as measured by Ctau, CL/F, and Vz/F [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    • Ctau is defined as the observed drug concentration at the end of the dosing interval
    • CL/F is the apparent oral clearance following administration of the drug
    • Vz/F is the apparent volume of distribution of the drug

  • Percentage of participants with plasma HIV-1 RNA < 50 and < 400 copies/mL [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline in plasma log10 HIV-1 RNA [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Tanner Stages at Weeks 24 and 48, and age of first menses [ Time Frame: Weeks 24 and 48 and age of first menses ] [ Designated as safety issue: No ]
    Tanner Stages at Weeks 24 and 48 will be summarized by baseline Tanner Stage using frequency and percentage. Age of first menses will be summarized descriptively.

  • Palatability of oral suspension formulation of EVG in appropriate age group [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Adherence to EVG [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Treatment adherence will be assessed at all post-baseline visits.

  • The change from baseline in CD4+ cell count (cells/μL) [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • The change from baseline in CD4 percentage [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2013
Estimated Study Completion Date: December 2033
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 (12 to < 18 years of age)

Part A: No participants will be enrolled in Part A, as PK data is currently available for this age group.

Part B: Participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG
Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally
Other Name: Vitekta®
Drug: Background regimen
Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.
Experimental: Cohort 2 (6 to < 12 years of age)

Part A: Participants will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG
Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally
Other Name: Vitekta®
Drug: Background regimen
Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.
Experimental: Cohort 3 (2 to < 6 years of age)

Part A: Participants will receive EVG plus a background regimen that includes a PI/r for 10 days. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG
Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally
Other Name: Vitekta®
Drug: Background regimen
Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.
Experimental: Cohort 4 (4 weeks to < 2 years of age)

Part A: Participants 6 months to < 2 years of age will be enrolled and upon review of safety and PK data, enrollment will be open for participants 4 weeks to < 6 months of age. Participants with HIV-1 RNA > 1,000 copies/mL who complete Part A may then choose to continue in Part B.

Part B: Following safety and PK assessment, participants will receive EVG plus a background regimen that includes a PI/r for up to 48 weeks.

Drug: EVG
Elvitegravir (EVG) tablets or tablets for oral suspension (if unable to swallow) will be administered orally
Other Name: Vitekta®
Drug: Background regimen
Background regimen may consist of the following RTV-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.

  Eligibility

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

Inclusion Criteria:

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

  • 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.

Exclusion Criteria:

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

  • 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
  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: NCT01923311

Contacts
Contact: Gilead Study Team GSUS1830160@gilead.com

  Show 32 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Sean Bennett, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01923311     History of Changes
Other Study ID Numbers: GS-US-183-0160, 2013-001969-16
Study First Received: August 9, 2013
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Pediatrics
Adolescents
HIV
HIV-1
Treatment-experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on July 30, 2015