Phase 2 Completed N=7 Other

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

Source: ClinicalTrials.gov NCT00518154 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcomePrimary: CD4+ Cell Count Change Between Basal and Week 16 of Additive Treatment — 153.2 CD4+ T-cell count/uL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY CD4+ Cell Count Change Between Basal and Week 16 of Additive Treatment	153.2	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00518154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.