Pyridostigmine as Immunomodulator in People Living With HIV

• Status: Suspended
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Adjuvants, Immunologic; Bromides; Cholinesterase Inhibitors; Immunologic Factors; Pyridostigmine Bromide

Criteria

Inclusion Criteria:

1. HIV-1 infected subjects 18 years of age or older

2. Receiving stable ART for at least six months

3. At least two undetectable viral load determinations in the previous six months

4. Patient agrees to participate and signs informed consent

Exclusion Criteria:

1. Concomitant active infectious or neoplastic disease

2. History of new AIDS-defining events in the previous six months

3. If a participant is female, pregnancy or breast-feeding

4. Exposure to an investigational agent, chemotherapy or radiotherapy within the previous 28 days

5. Currently taking or planning to take treatment for Tuberculosis

6. Being unable to follow or comply with the protocol interventions

7. The participant is receiving immunosuppressive treatment, including corticosteroids