Clinical Trial Details

NCT ID: NCT02016924
Date Last Changed: October 3, 2017

Overview

Research Study Summary

A Phase 2/Phase 3 clinical study for patients with Acquired Immune Deficiency Syndrome (AIDS) or HIV Infections

Research Study Title

A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered With Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Suppressed Pediatric Subjects

Purpose

The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically suppressed, pediatric participants between the ages of 3 months to < 18 years of age.

This study will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each co-administered with a background regimen (BR) through 48 weeks and during the 5 year long-term treatment.

There will be 2 parts to the study.

  • Part A: Participants will be enrolled sequentially by age cohort to evaluate the steady state PK and confirm dose of ATV/co and DRV/co. Following screening, enrolled participants will continue their suppressive regimen of either ATV/r or DRV/r once-daily plus their BR. On Day 1, participants will discontinue ritonavir and initiate once daily cobicistat (COBI) to be taken with their ATV or DRV plus their BR. All participants enrolled in Part A will participate in an intensive PK evaluation of COBI and ATV or DRV on Day 10. Following completion of the intensive PK visit, participants will continue to receive COBI coadministered with DRV or ATV each with a BR and return for scheduled study visits.

  • Part B: Participants will be enrolled to evaluate the safety, tolerability, and efficacy of the ATV/co or DRV/co regimen. For all cohorts in Part B, participants will be screened and initiated sequentially by each age cohort following confirmation of appropriate COBI exposure and PI exposures from the corresponding age cohort in Part A.

To Learn more

Recruitment Details

Phase
2/3
Gender
All
Age
3 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Gilead Sciences
Duration
83 Months
Facility Type
N/A
Compensation

Eligibility

All ages 3 Months to 17 Years

Key Inclusion Criteria:

  • HIV-1 infected treatment-experienced, virologically suppressed males and females aged 3 months to < 18 years at the Day 1 visit (according to requirements of enrolling Cohort)

  • 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 ≥ 25 kg (Cohorts 1 and 2), 15 kg to < 25 kg (Cohort 2), or to be determined (Cohorts 3 and 4) dependent upon age cohort

  • Adequate renal function

  • Adequate hematologic function

  • Adequate hepatic function defined as

  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

  • Total bilirubin ≤ 1.5 mg/dL or a normal direct bilirubin

  • Negative serum pregnancy test

  • Individuals with evidence of suppressed viremia ( < 50 copies/mL) at study entry

  • Stable antiretroviral regimen including 2 nucleoside reverse transcriptase inhibitors and either ritonavir-boosted atazanavir or ritonavir-boosted darunavir once or twice daily as per product label for a minimum of 3 months prior to the screening visit. Treatment-experienced pediatric individuals taking DRV/r must have no history of DRV resistance associated mutations.

  • Males and females of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period and for 30 days following the last dose of study drug

  • Documented negative screening for active pulmonary tuberculosis (TB) per local standard of care within 6 months of a screening visit

  • Must be willing and able to comply with all study requirements

  • No opportunistic infection within 30 days of study entry (at Day -10)

Key Exclusion Criteria:

  • Individuals with CD4+ cell counts at screening of less than 200 cells/mm^3

  • An AIDS defining condition with onset within 30 days prior to screening

  • Life expectancy of less than 1 year

  • An ongoing serious infection requiring systemic antibiotic therapy at the time of screening.

  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease:

  • Within 3 months of the screening visit for all individuals 6 months of age or older

  • At anytime for individuals younger than 6 months

  • Anticipated requirement for rifamycin treatment while participating in the study. Note: prophylactic isoniazid therapy for latent TB is allowed.

  • Active hepatitis C virus (HCV) infection. Note: individuals with positive HCV antibody and without detectable HCV RNA are permitted to enroll.

  • Positive Hepatitis B surface antigen or other evidence of active hepatitis B virus (HBV) infection. Note: individuals with positive HBV surface antibody and no evidence of active HBV infection are permitted to enroll.

  • Individuals with clinically significant abnormal ECGs

  • Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with 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 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, including observational studies, 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 COBI or a component of the BR

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Site Locations (9)

Country State City Zip Facility and Contact
United States California Long Beach 90806 Pediatric Infectious Diseases Associate

Jagmohan Batra, MD
Principal Investigator
United States Colorado Aurora 80045 Children's Hospital Colorado

Elizabeth McFarland, MD
Principal Investigator
United States Florida Tampa 33620 University of South Florida Clinic at Children's Medical Services

Carina Rodriguez, MD
Principal Investigator
United States Tennessee Memphis 38105 St. Jude Children's Research Hospital

Aditya Gaur, MD
Principal Investigator
United States Texas Houston 77030 University of Texas Health Science Center of Houston

Gloria Heresi, MD
Principal Investigator
Argentina Buenos Aires C1131ACG Helios Salud S.A.

Maria R Bologna
Principal Investigator
Thailand Khon Kaen Amphur Muang Srinagarind Hospital Khon Kaen University

Pope Kosalaraksa
Principal Investigator
Thailand Krung Thep Maha Nakhon Bangkok Siriraj Hospital Mahidol University

Kulkanya Chokephaibulkit
Principal Investigator
Thailand Krung Thep Maha Nakhon Bangkok The HIV NAT Research Collaboration

Sivaporn Gatechompol
Principal Investigator

Contact

Gilead Study Team

E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.