NCT02291809

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
3 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

November 6, 2014

Last Update Submit

February 22, 2016

Conditions

HIV/AIDS

Keywords

HIV/AIDSPediatricVaccineHIV-1 Immunogen

Outcome Measures

Primary Outcomes (2)

  • The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52

    The primary objective is to compare \& evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52

    52 Weeks

  • The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts 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

    52 Weeks

Secondary Outcomes (3)

  • The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups

    52

  • 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

    52 Weeks

  • The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE

    52 Weeks

Study Arms (2)

REMUNE

EXPERIMENTAL

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.

Biological: REMUNE

REMUNE Low Dose

PLACEBO COMPARATOR

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.

Biological: REMUNE

Interventions

REMUNEBIOLOGICAL

Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

Also known as: HIV-1 Immunogen
REMUNEREMUNE Low Dose

Eligibility Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Truvada
  • Triple cocktail HAART drugs
  • Healthy subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site TBA

San Diego, California, 92101, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

remuneHIV-1 immunogen, incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Richard M Bartholomew, PhD

    Immune Response BioPharma, Inc. Chief R&D Officer

    STUDY DIRECTOR

Central Study Contacts

Richard M Bartholomew, PhD

CONTACT

(858) 414-4664richardmbartholomew@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 14, 2014

Study Start

November 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)