HIV InfectionsFATHIVNCT05687565
Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
A study testing Experimental group 1 lauric acid and Experimental group 2 lauric acid in people with HIV Infections, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Experimental group 1 lauric acid and Experimental group 2 lauric acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 27 Sep 2022to 21 Dec 2025
- 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-1 infected men or women ≥18 years old
- Not having interrupted current antiretroviral treatment at least 6 months before the screening visit.
- Acceptable stable ART regimens prior to screening include 2 more NRTIs: INI or NNRTI or boosted PI.
- Documented prior evidence of at least 2 years prior to enrollment with a serum HIV RNA load of <50 RNA copies/ml (viral load of >50 copies but <200 is allowed).
- Plasma HIV-1 RNA <50 c/ml at screening visit.
- CD4 T cell count > 300 cells/µL at screening visit.
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- A woman may be eligible to enroll and participate in the study if:
- Not pregnant, not of childbearing potential or physically unable to become pregnant
- You are of childbearing potential with a negative pregnancy test at the screening visit and agree to use contraception to prevent pregnancy.
Who cannot join
- Have suffered any significant acute illness in the last 8 weeks.
- Having been diagnosed in the past or present with an AIDS-defining illness
- Previous CD4 T cell count <200 cells/μL.
- Having suffered an infection with Hepatitis B or C
- Having any disease or condition that in the investigator's opinion is not appropriate for the patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall d´Hebron
Barcelona, 08035
Joaquin Burgos, MD, 93 4896090, joaquin.burgos@vallhebron.cat
About this study
Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity.
Design: Pilot, randomized, placebo-controlled, patient-blind study. Patients ≥18 years old with HIV-1 receiving stable ART (no change in ART for at least 6 months) and a serum HIV RNA load of < 50 RNA copies/mL for at least 2 years and with a CD4 T cell count >300 cells/μl will be randomized 1:1:1 to dietary supplementation with placebo (controlled group) or lauric acid 1.5 g once daily (experimental group 1) or with lauric acid 3 g once daily (experimental group 2) for 24 consecutive weeks.
Primary objective: To assess the effect of dietary lauric acid supplementation, compared with placebo, on the reactivation of HIV transcription in latently infected CD4 T cells in HIV-infected patients on suppressive antiretroviral therapy.
- Conditions
- HIV Infections
- Being tested
- Control group placebo, Experimental group 1 lauric acid, Experimental group 2 lauric acid
- Keywords
- lauric acid, HIV, antiretroviral treatment
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group placeboDietary supplement
Dietary suplementation
Experimental group 1 lauric acidDietary supplement
Lauric acid 1.5 grams once daily
Experimental group 2 lauric acidDietary supplement
Lauric acid 3 grams once daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Dietary supplementation Receives: Dietary Supplement: Control group placebo |
| Experimental group 1 | Experimental | 1.5 grams once daily during 48 weeks Receives: Dietary Supplement: Experimental group 1 lauric acid |
| Experimental group 2 | Experimental | 3 grams once daily during 48 weeks Receives: Dietary Supplement: Experimental group 2 lauric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective of lauric acid in HIV
Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.
Measured: 48 weeks
Secondary outcomes (4)
Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
To dertermine the effetive of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
Measured: 48 weeks
Effective of lauric acid on the production of HIV-1 viral
To dertermine the effetive of lauric acid on on the production of HIV-1 viral (viral load)
Measured: 48 weeks
Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
To dertermine the effetive of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
Measured: 48 weeks
Evaluate Lauric acid plasmatic levels
To evaluate Lauric acid with high performance liquid chromatography (HPLC).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start27 Sep 2022
- Primary completion21 Nov 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687565
- Sponsor's protocol ID
- PR(AG)12/2022
- Acronym
- FATHIV
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV
- ClinicalTrials.gov ID
- NCT05687565
- Acronym / sponsor ID
- FATHIV / PR(AG)12/2022
- Conditions
- HIV Infections
- Keywords
- lauric acid, HIV, antiretroviral treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 21 Nov 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 18 Jan 2023 (actual)
- 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.
Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity.
Design: Pilot, randomized, placebo-controlled, patient-blind study. Patients ≥18 years old with HIV-1 receiving stable ART (no change in ART for at least 6 months) and a serum HIV RNA load of < 50 RNA copies/mL for at least 2 years and with a CD4 T cell count >300 cells/μl will be randomized 1:1:1 to dietary supplementation with placebo (controlled group) or lauric acid 1.5 g once daily (experimental group 1) or with lauric acid 3 g once daily (experimental group 2) for 24 consecutive weeks.
Primary objective: To assess the effect of dietary lauric acid supplementation, compared with placebo, on the reactivation of HIV transcription in latently infected CD4 T cells in HIV-infected patients on suppressive antiretroviral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Control group placeboDietary supplementation |
| Experimental group 1 | Experimental | Dietary Supplement: Experimental group 1 lauric acid1.5 grams once daily during 48 weeks |
| Experimental group 2 | Experimental | Dietary Supplement: Experimental group 2 lauric acid3 grams once daily during 48 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infected men or women ≥18 years old
- Not having interrupted current antiretroviral treatment at least 6 months before the screening visit.
- Acceptable stable ART regimens prior to screening include 2 more NRTIs: INI or NNRTI or boosted PI.
- Documented prior evidence of at least 2 years prior to enrollment with a serum HIV RNA load of <50 RNA copies/ml (viral load of >50 copies but <200 is allowed).
- Plasma HIV-1 RNA <50 c/ml at screening visit.
Key exclusion criteria (5 listed)
- Have suffered any significant acute illness in the last 8 weeks.
- Having been diagnosed in the past or present with an AIDS-defining illness
- Previous CD4 T cell count <200 cells/μL.
- Having suffered an infection with Hepatitis B or C
- Having any disease or condition that in the investigator's opinion is not appropriate for the patient's participation in the study.
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 |
|---|---|---|
| Control group placeboDietary suplementation | Dietary supplement | Control group |
| Experimental group 1 lauric acidLauric acid 1.5 grams once daily | Dietary supplement | Experimental group 1 |
| Experimental group 2 lauric acidLauric acid 3 grams once daily | Dietary supplement | Experimental group 2 |
Primary outcome
Effective of lauric acid in HIV
Time frame: 48 weeks
Number of patients on a lauric acid diet presenting a response on the reactivation of HIV transcription in CD4 T cells.
4 secondary outcomes
Effective of lauric acid on the size of the latent HIV-1 reservoir in CD4 T cells
Time frame: 48 weeks
Effective of lauric acid on the production of HIV-1 viral
Time frame: 48 weeks
Effective of lauric acid on the size of the HIV-1 reservoir in intestinal tissue
Time frame: 48 weeks
Evaluate Lauric acid plasmatic levels
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group 1 lauric acid and Experimental group 2 lauric acid in people with HIV Infections, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 9 inclusion and 5 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 18 Jan 2023. 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 Spain. 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.
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 Joaquin Burgos, MD (93 4896090, joaquin.burgos@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective of lauric acid in HIV (time frame: 48 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 18 Jan 2023.