HIV/AIDSPhase 2NCT02291809
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
A Phase 2 study testing REMUNE in people with HIV/AIDS, 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 \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- REMUNE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2017to Nov 2019
- Phase
- Phase 2
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Truvada
- Triple cocktail HAART drugs
- Healthy subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Site TBA
San Diego, California, 92101
Richard M 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 \& 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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- REMUNE
- Keywords
- HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMUNEBiological
Also called HIV-1 Immunogen
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: REMUNE |
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 (HIV RNA Viral Load) at Week 52
Measured: 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
Measured: 52 Weeks
Secondary outcomes (3)
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
Measured: 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
HIV-1 immunogen on viral replication in children with HIV-1 infection
Measured: 52 Weeks
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
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
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 posted14 Nov 2014 (estimated)
- Study startNov 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Response BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard M Bartholomew, PhD, Study director, Immune Response BioPharma, Inc. Chief R&D Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291809
- Sponsor's protocol ID
- IR-HIV-007
- Status last verified
- Feb 2016
- First submitted
- 6 Nov 2014
- 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 HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
- ClinicalTrials.gov ID
- NCT02291809
- Acronym / sponsor ID
- IR-HIV-007
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Immune Response BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2017
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 14 Nov 2014 (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 \& 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMUNE | Experimental | Biological: REMUNERemune 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. |
| REMUNE Low Dose | Placebo comparator | Biological: REMUNERemune 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. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Truvada
- Triple cocktail HAART drugs
- Healthy subjects
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 |
|---|---|---|
| REMUNEAlso: HIV-1 ImmunogenInoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine | Biological | REMUNE, REMUNE Low Dose |
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 (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
3 secondary outcomes
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 the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection
Time frame: 52 Weeks
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
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 M Bartholomew, PhD study director
Immune Response BioPharma, Inc. Chief R&D Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REMUNE in people with HIV/AIDS, 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 M 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). The study lists 2 primary outcomes in all. 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.