Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the addition of Pyridostigmine to Highly Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant patients in which viral load diminishes, but T-cell levels remain low after the initiation of treatment.

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

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Pyridostigmine Bromide

Criteria

Inclusion Criteria:

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

• Receiving HAART for at least two years

• At least a viral load determination per year since HAART initiation, all undetectable

• Patient's status is Immunological Non Responder (InR), that is, his or her viral load is reduced, but CD4+ cell count has not raised accordingly

• Current viral load: undetectable

• Patient agrees and signs informed consent

Exclusion Criteria:

• Concomitant active infectious or neoplastic disease

• History of new AIDS-defining events during HAART

• Pregnancy or breast-feeding

• Patients who have been subjects of an investigational agent, chemotherapy or radiotherapy within the previous 28 days

• Subjects requiring treatment for Tuberculosis

• Subjects unable to follow, or comply with the protocol interventions

• Subjects receiving immunosuppressive treatment, including corticosteroids