HIVPhase 3RAISENCT02366026
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
A Phase 3 study testing IR103 in people with HIV, run by Immune Response BioPharma, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV
- What is being tested?
- IR103
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2017to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Healthy Subjects
- Currently abuse alcohol or drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Site TBA
San Diego, California, 92101
Richard Bartholomew, PhD, 858-414-4664, RichardmBartholomew@gmail.com
About this study
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.
Read the detailed description
This is a 500 subject Multi Center double-blind randomized, Safety \& Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen \& Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection \& to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.
- Conditions
- HIV
- Being tested
- IR103
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR103Biological
Also called HIV-1 IMMUNOGEN + Amplivax, REMUNE + Amplivax
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: IR103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 Weeks
Secondary outcomes (2)
The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups
The secondary objective is to evaluate \& compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52
Measured: 52 Weeks
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 changes in CD4+ \& CD8+ T cell counts between the treatment groups at Week 52
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJun 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Response BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Bartholomew, PhD, Study director, Immune Response BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366026
- Sponsor's protocol ID
- IR103-007
- Acronym
- RAISE
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
- ClinicalTrials.gov ID
- NCT02366026
- Acronym / sponsor ID
- RAISE / IR103-007
- Conditions
- HIV
- Keywords
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Immune Response BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2017
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 500 subject Multi Center double-blind randomized, Safety \& Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen \& Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection \& to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IR103 REMUNE + AMPLIVAX 1.0 | Experimental | Biological: IR103IR103 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). |
| AMPLIVAX 1.0 + IFA | Placebo comparator | Biological: IR103AMPLIVAX 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Healthy Subjects
- Currently abuse alcohol or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IR103Also: HIV-1 IMMUNOGEN + Amplivax, REMUNE + AmplivaxREMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax | Biological | AMPLIVAX 1.0 + IFA, IR103 REMUNE + AMPLIVAX 1.0 |
Primary outcome
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 at Week 52
2 secondary outcomes
The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups
Time frame: 52 Weeks
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
Time frame: 52 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bartholomew, PhD study director
Immune Response BioPharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IR103 in people with HIV, run by Immune Response BioPharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Bartholomew, PhD. (858-414-4664, RichardmBartholomew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.