NCT02366026

Brief Summary

The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts \& 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
500

participants targeted

Target at P50-P75 for phase_3 hiv

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_3 hiv

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

February 6, 2015

Last Update Submit

February 22, 2016

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • 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 at Week 52

    52 Weeks

Secondary Outcomes (2)

  • The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups

    52 Weeks

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

    52 Weeks

Study Arms (2)

IR103 REMUNE + AMPLIVAX 1.0

EXPERIMENTAL

IR103 Vaccine contain the same active component as REMUNE® (Inactivated HIV-1 Antigen Drug Substance at 10 μg/mL p24 dose), and have one dose of Amplivax™ (HYB2055) Adjuvant (1.0 mg) added before emulsification in Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).

Biological: IR103

AMPLIVAX 1.0 + IFA

PLACEBO COMPARATOR

AMPLIVAX 1.0 mg Amplivax™ (HYB2055) Adjuvant (1.0 mg) + IFA Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).

Biological: IR103

Interventions

IR103BIOLOGICAL

REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax

Also known as: HIV-1 IMMUNOGEN + Amplivax, REMUNE + Amplivax
AMPLIVAX 1.0 + IFAIR103 REMUNE + AMPLIVAX 1.0

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
  • Are at least 16 years old (consent of parent or guardian required if under 18 years).

You may not qualify if:

  • Healthy Subjects
  • Currently abuse alcohol or drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site TBA

San Diego, California, 92101, United States

Location

MeSH Terms

Interventions

IMO-2055remune

Study Officials

  • Richard Bartholomew, PhD

    Immune Response BioPharma, Inc.

    STUDY DIRECTOR

Central Study Contacts

Richard Bartholomew, PhD.

CONTACT

858-414-4664RichardmBartholomew@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
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

February 6, 2015

First Posted

February 19, 2015

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)