Pyridostigmine as Immunomodulator in People Living With HIV (NCT03312244) | Clinical Trial Compass
SuspendedPhase 2
Pyridostigmine as Immunomodulator in People Living With HIV
Stopped: Due to COVID-19, effective 3/19/2020 recruitment is halted until further notice
Mexico60 participantsStarted 2019-07-01
Plain-language summary
Human immunodeficiency virus (HIV) infection is characterized by persistent immune activation and a constant turnover of T cells. This leads to a precipitous fall in the number of T cells, as well as to an early immunosenescence. This results in increased susceptibility to opportunistic infections. In these patients, modulation of the immune response represents a promising mechanism to maintain immunological homeostasis and prevent the development of pathology. We hypothesize that the addition of pyridostigmine to the regular combined antiretroviral therapy will result in a decrease in T cell overactivation and a reduction in circulating inflammatory markers.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. HIV-1 infected subjects 18 years of age or older
✓. Receiving stable ART for at least six months
✓. At least two undetectable viral load determinations in the previous six months
✓. Patient agrees to participate and signs informed consent
Exclusion criteria
✕. Concomitant active infectious or neoplastic disease
✕. History of new AIDS-defining events in the previous six months
✕. If a participant is female, pregnancy or breast-feeding
✕. Exposure to an investigational agent, chemotherapy or radiotherapy within the previous 28 days
✕. Currently taking or planning to take treatment for Tuberculosis
✕. Being unable to follow or comply with the protocol interventions
What they're measuring
1
CD4+ T cell count
Timeframe: Change from baseline, at 12 and 24 weeks
Trial details
NCT IDNCT03312244
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran