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FotoBio-HIV: evaluation of Laser Therapy on Inflammatory, Immunological, and Coagulation Processes in People Living with HIV/AIDS

PhotoBio-HIV: evaluation of the effects of Vascular Photobiomodulation on Inflammatory, Immunological, and Coagulation Biomarkers in people living with HIV/AIDS – clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3mcg82f
Enrollment
Unknown
Registered
2024-12-05
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Mediators

Interventions

The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial. The randomization of the 105 participants will be performed through block random allocation, using R softw
E02.594.540

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must have been diagnosed with HIV/AIDS for at least one year; be over 18 years of age; both sexes; be on regular antiretroviral therapy for at least six consecutive months; be in viral suppression (undetectable or less than the minimum limit); must not present active opportunistic infections at the time of study enrollment

Exclusion criteria

Exclusion criteria: People under 18; pregnant women; patients with active opportunistic infections; history of neoplasms; carriers of active electronic implants such as cardiac pacemakers; those with a history of epilepsy or seizures; people with known photosensitivity conditions

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to evaluate the impact of non-invasive transcutaneous photobiomodulation on biomarkers in patients living with HIV/AIDS who are on antiretroviral therapy. The analysis will focus on changes in the levels of interleukins (IL-1ß, IL-6, IL-10) and tumor necrosis factor-alpha (TNF-alpha) before and after the intervention. The study will also examine changes in levels of D-dimer, high-sensitivity C-reactive protein (hs-CRP), and nitric oxide to assess blood coagulation, inflammatory status, and endothelial function. The expected results include significant reductions in inflammatory markers and improvements in immunological and hematological parameters, suggesting that photobiomodulation may be an effective adjunct in the management of HIV/AIDS, with the potential to optimize treatment protocols.—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactJean;Erildo Sandeski Zuber;Muller

Universidade Estadual de Ponta Grossa; Universidade Estadual de Ponta Grossa

jean2202@gmail.com;erildomuller@uepg.br+55-42-33203350;+55-42-33203350

Outcome results

None listed

Source: REBEC (via WHO ICTRP)