HIV InfectionsNCT04460924
ARTiBIOME: Observational Study on the Effect of HIV and ART on Gut Microbiome
An observational study of HIV Infections, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Integrase strand transfer inhibitors
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 1 Mar 2023
- Phase
- Observational
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will compare 20 MSM HIV negative patients starting PEP with INSTI with: * 20 MSM HIV-uninfected and ART naïve (A) * 20 MSM HIV-infected starting ART (B) * 20 MSM HIV-infected on ART with >500 CD4 Tcells ( C ) * 20 MSM HIV-infected on ART with <350 CD4 Tcells (D) (the study population has been restricted to MSM given the strong influence of sexual orientation on the microbiota composition
Who may be able to join
- Willing to sign consent form
- Men with an age >18 years
- Engagement in insertive or receptive anal intercourse with another men
Who cannot join
- Previous history of ART exposure
- Use of antibiotics in the past 3 months
- Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Ramón y Cajal and Hospital Clínico San Carlos
Madrid, 28034
About this study
Official title: ARTiBIOME: Effect of HIV and ART on Gut Microbiome
Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations.
The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.
- Conditions
- HIV Infections
- Being tested
- Integrase strand transfer inhibitors
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrase strand transfer inhibitorsDrug
Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
| Study group | Role | What they receive |
|---|---|---|
| MSM HIV-uninfected and ART naïve | Men who have sex with men without HIV infection, not receiving ART | |
| MSM HIV-infected starting ART | Men who have sex with men with HIV infection, starting ART Receives: Drug: Integrase strand transfer inhibitors | |
| MSM HIV-infected on ART with >500 CD4 Tcells | Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL Receives: Drug: Integrase strand transfer inhibitors | |
| MSM HIV-infected on ART with <350 CD4 Tcells | Men who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL Receives: Drug: Integrase strand transfer inhibitors | |
| MSM HIV negative patients starting PEP with INST | Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir Receives: Drug: Integrase strand transfer inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity changes of fecal microbiota composition
Alpha diversity changes of fecal microbiota composition between study groups
Measured: Baseline and 1 month, 3 months, 12 months
Beta diversity changes of fecal microbiota composition
Beta diversity changes of fecal microbiota composition between study groups
Measured: Baseline and 1 month, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Nov 2020
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 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
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460924
- Sponsor's protocol ID
- ARTiBIOME: Observational study
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTiBIOME: Effect of HIV and ART on Gut Microbiome
- ClinicalTrials.gov ID
- NCT04460924
- Acronym / sponsor ID
- ARTiBIOME: Observational study
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Jul 2020 (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.
Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations.
The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MSM HIV-uninfected and ART naïve | – | –Men who have sex with men without HIV infection, not receiving ART |
| MSM HIV-infected starting ART | – | Drug: Integrase strand transfer inhibitorsMen who have sex with men with HIV infection, starting ART |
| MSM HIV-infected on ART with >500 CD4 Tcells | – | Drug: Integrase strand transfer inhibitorsMen who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL |
| MSM HIV-infected on ART with <350 CD4 Tcells | – | Drug: Integrase strand transfer inhibitorsMen who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL |
| MSM HIV negative patients starting PEP with INST | – | Drug: Integrase strand transfer inhibitorsMen who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will compare 20 MSM HIV negative patients starting PEP with INSTI with: * 20 MSM HIV-uninfected and ART naïve (A) * 20 MSM HIV-infected starting ART (B) * 20 MSM HIV-infected on ART with >500 CD4 Tcells ( C ) * 20 MSM HIV-infected on ART with <350 CD4 Tcells (D) (the study population has been restricted to MSM given the strong influence of sexual orientation on the microbiota composition
Key inclusion criteria (3 listed)
- Willing to sign consent form
- Men with an age >18 years
- Engagement in insertive or receptive anal intercourse with another men
Key exclusion criteria (3 listed)
- Previous history of ART exposure
- Use of antibiotics in the past 3 months
- Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.
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 |
|---|---|---|
| Integrase strand transfer inhibitorsIntegrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment | Drug | MSM HIV negative patients starting PEP with INST, MSM HIV-infected on ART with <350 CD4 Tcells, MSM HIV-infected on ART with >500 CD4 Tcells, MSM HIV-infected starting ART |
Primary outcome
Alpha diversity changes of fecal microbiota composition
Time frame: Baseline and 1 month, 3 months, 12 months
Alpha diversity changes of fecal microbiota composition between study groups
Beta diversity changes of fecal microbiota composition
Time frame: Baseline and 1 month, 3 months, 12 months
Beta diversity changes of fecal microbiota composition between study groups
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 13 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal 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 3 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: finished, as of the sponsor's last update on 13 Sep 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. 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?
Alpha diversity changes of fecal microbiota composition (time frame: Baseline and 1 month, 3 months, 12 months). 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 13 Sep 2023.