HIV Infection AsymptomaticPROMALTIANCT03009032
Synbiotics in Advanced HIV Infection
A study testing PMT25341 in people with HIV Infection Asymptomatic, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
Trial summary
Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infection Asymptomatic
- What is being tested?
- PMT25341
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2017
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS
- Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines
Who cannot join
- Age <18 years
- Pregnancy
- Type 1 or 2 diabetes
- End-stage renal disease
- Lactose intolerance
- Use of immunomodulatory drugs
- Neutrophil count <750cells/uL
About this study
Official title: Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.
- Conditions
- HIV Infection Asymptomatic
- Being tested
- PMT25341, Placebo
- Keywords
- HIV, immunologic recovery, microbiota, prebiotics, probiotics, synbiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMT25341Dietary supplement
PlaceboDietary supplement
Lactose
| Study group | Role | What they receive |
|---|---|---|
| PMT25341 | Experimental | A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids Receives: Dietary Supplement: PMT25341 |
| PLACEBO | Placebo comparator | Lactose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From baseline through week 48
Changes in CD4+ T cell counts/uL
Measured: From baseline through week 48
Changes in CD8+ T cell counts/uL
Measured: From baseline through week 48
Changes in CD4/CD8 ratio
Measured: From baseline through week 48
Secondary outcomes (9)
Microbiota composition: alpha-diversity
Measured: From baseline through week 48
Microbiota composition: Unifrac distances
Measured: From baseline through week 48
Microbiota composition: Canberra distances
Measured: From baseline through week 48
Changes in plasma soluble CD14 levels
Measured: From baseline through week 48
Changes in plasma hs-CRP levels
Measured: From baseline through week 48
Changes in plasma IFABP levels
Measured: From baseline through week 48
Changes in plasma lipoteichoic acid levels
Measured: From baseline through week 48
Changes in plasma kynurenine/tryptophan ratio
Measured: From baseline through week 48
Changes in percentage of HLADR+/CD38+ T cells
Measured: From baseline through week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startFeb 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infection AsymptomaticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital San Pedro de Logroño, Hospital del Mar
- Responsible party
- Principal investigator, Sergio Serrano-Villar, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009032
- Sponsor's protocol ID
- 14/016
- Acronym
- PROMALTIA
- Status last verified
- Jul 2017
- First submitted
- 28 Dec 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
- ClinicalTrials.gov ID
- NCT03009032
- Acronym / sponsor ID
- PROMALTIA / 14/016
- Conditions
- HIV Infection Asymptomatic
- Keywords
- HIV, immunologic recovery, microbiota, prebiotics, probiotics, synbiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital San Pedro de Logroño, Hospital del Mar
- Study start
- Feb 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jan 2017 (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.
Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.
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 |
|---|---|---|
| PMT25341 | Experimental | Dietary Supplement: PMT25341A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids |
| PLACEBO | Placebo comparator | Dietary Supplement: PlaceboLactose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS
- Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy
- Type 1 or 2 diabetes
- End-stage renal disease
- Lactose intolerance
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 |
|---|---|---|
| PMT25341 | Dietary supplement | PMT25341 |
| PlaceboLactose | Dietary supplement | PLACEBO |
Primary outcome
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From baseline through week 48
Changes in CD4+ T cell counts/uL
Time frame: From baseline through week 48
Changes in CD8+ T cell counts/uL
Time frame: From baseline through week 48
Changes in CD4/CD8 ratio
Time frame: From baseline through week 48
9 secondary outcomes
Microbiota composition: alpha-diversity
Time frame: From baseline through week 48
Microbiota composition: Unifrac distances
Time frame: From baseline through week 48
Microbiota composition: Canberra distances
Time frame: From baseline through week 48
Changes in plasma soluble CD14 levels
Time frame: From baseline through week 48
Changes in plasma hs-CRP levels
Time frame: From baseline through week 48
Changes in plasma IFABP levels
Time frame: From baseline through week 48
Changes in plasma lipoteichoic acid levels
Time frame: From baseline through week 48
Changes in plasma kynurenine/tryptophan ratio
Time frame: From baseline through week 48
Changes in percentage of HLADR+/CD38+ T cells
Time frame: From baseline through week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PMT25341 in people with HIV Infection Asymptomatic, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
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 7 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: From baseline through week 48). The study lists 4 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 1 Aug 2017.