NCT07367867Completed
Inflammation in HIV/AIDS-InflammAIDS
Inflammation in HIV/AIDS-InflammAIDS: an Observational Multicenter Cohort Study Protocol
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) pandemic still represents a major public health problem with 41 million people currently living with HIV worldwide. Indeed, the advent of antiretroviral therapy (ART) has largely decreased morbidity and mortality associated with HIV/AIDS. Nevertheless, ART is not able to eradicate the virus and, therefore, the management of HIV/AIDS involves a long-term treatment. The persistence of an HIV reservoir is associated with a chronic status of immune activation and inflammation, exacerbating damage in tissues. Consequently, the immunological status of people living with HIV (PLWH) is reminiscent to what is observed in immunosenescence, predisposing them to the development of the so-called non-AIDS defining diseases (NADE), which correspond to conditions commonly observed in aging such as metabolic syndrome, cardiovascular diseases, diabetes, neurocognitive disorders, and non-HIV associated cancers, amongst others. The investigators estimate that more than a half of Chilean patients present metabolic syndrome, a well characterized risk factor including cardiovascular disease , type 2 diabetes and death in the general population but especially in PLWH. The Anillo Inflammation in HIV/AIDS (InflammAIDS) brings together an interdisciplinary group of researchers from life and medical sciences working at public universities and hospitals with the aim of investigating the immune, inflammatory and virological signatures of PLWH with and without metabolic syndrome in Chile and how they influence the clinical outcome of the patients. To accomplish our objectives, the researchers group will first establish a prospective cohort of PLWH, with and without metabolic syndrome, across relevant lifetime periods (childhood, adulthood, and elderly) and will generate the first Chilean collection of samples from the participants of this clinical cohort with Biobank standards, generation standardized and high-quality sample and data collection. These cohorts will be analyzed combining state-of-the-art methodologies such as single-cell RNA sequencing, multiparametric flow cytometry, xMap® Luminex, mass spectrometry and Oxford Nanopore Technologies sequencing together with classical biochemical, molecular, and cellular biology, virological and immunological analyses, determining the immune, inflammatory and virological state associated to the clinical condition of our patients.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 320 (actual)
- First submitted
- 19 Aug 2025
- Start date
- 6 Mar 2023
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Universidad de Magallanes
- Diseases
- HIV
- NCT number
- NCT07367867
What you commit to
- Study type: Observational
- Participants enrolled: 320
- From 6 Mar 2023 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- The following inclusion criteria will be considered in the adult cohort:
- Adults over 18 years
- Signed informed consent
- HIV diagnosis confirmed by the Public Health Institute
- Patients under clinical control in any of the participating centers
- Availability to attend the taking of samples and medical controls
- The following inclusion criteria will be considered in the pediatric cohort:
- Infants and children younger 18 years
- Patients under control in any of the participating center
- Signed informed consent by parents or legal guardians of the minor. In children 8 years and older, also informed assent
- In infants under 4 months of life, HIV diagnosis by a first positive RT-PCR for HIV performed at the Public Health Institute. In infants and children over 4 months, HIV diagnosis is confirmed by the Public Health Institute.
- Children exposed to HIV during pregnancy, labor or breastfeeding of mothers with confirmed HIV, with a negative diagnosis.
- Availability to attend the taking of samples and medical controls, and without medical contraindications for taking the samples (severe anemia according to age).
- The following exclusion criteria will be considered in both cohorts:
- \- The only exclusion criterion will be the patient's refusal to participate in the case of adults and in the case of minors, the non-signature of the informed consent by the legal guardians and the minor's non-assent.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Asistencial Docente y de Investigación, Universidad de Magallanes Coordinator of this site? Confirm its status | Punta Arenas | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.