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REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291809
Recruitment Status : Unknown
Verified February 2016 by Immune Response BioPharma, Inc..
Recruitment status was:  Not yet recruiting
First Posted : November 14, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.

Tracking Information
First Submitted Date  ICMJE November 6, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE November 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 [ Time Frame: 52 Weeks ]
    The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52
  • The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52 [ Time Frame: 52 Weeks ]
    The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups [ Time Frame: 52 ]
    The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
  • The secondary objective is to evaluate & compare the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection [ Time Frame: 52 Weeks ]
    HIV-1 immunogen on viral replication in children with HIV-1 infection
  • The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE [ Time Frame: 52 Weeks ]
    The secondary objective is to evaluate & compare between the treatment groups the ability to induce immune responses between the adult and low doses of REMUNE
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Official Title  ICMJE REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Brief Summary The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.
Detailed Description This is a 26 subject Multi Center double-blind randomized, Safety & Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection & immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Biological: REMUNE
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
Other Name: HIV-1 Immunogen
Study Arms  ICMJE
  • Experimental: REMUNE
    Remune vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 10 μg of p24 antigen in approximately 100 μg of total protein.
    Intervention: Biological: REMUNE
  • Placebo Comparator: REMUNE Low Dose
    Remune low dose vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 2.5 μg of p24 antigen in approximately 25 μg of total protein.
    Intervention: Biological: REMUNE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
  • Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs

Exclusion Criteria:

  • Truvada
  • Triple cocktail HAART drugs
  • Healthy subjects
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291809
Other Study ID Numbers  ICMJE IR-HIV-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immune Response BioPharma, Inc.
Study Sponsor  ICMJE Immune Response BioPharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard M Bartholomew, PhD Immune Response BioPharma, Inc. Chief R&D Officer
PRS Account Immune Response BioPharma, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP