NCT00518154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
10.9 years until next milestone

Results Posted

Study results publicly available

November 14, 2019

Completed
Last Updated

November 14, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

August 17, 2007

Results QC Date

October 10, 2017

Last Update Submit

October 24, 2019

Conditions

HIV Infections

Keywords

AIDSImmunological non-respondersNeuroimmune modulationPyridostigmineTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • CD4+ Cell Count Change Between Basal and Week 16 of Additive Treatment

    Change in total CD4+ T-cell number from baseline to addition of pyridostigmine

    16 weeks after initiation of pyridostigmine

Study Arms (1)

A

EXPERIMENTAL

Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment

Drug: Pyridostigmine tablets

Interventions

Pyridostigmine tabletsDRUG

Patients will take 30mg tid PO for 12 weeks

Also known as: Mestinon
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sergio I. Valdés-Ferrer

Mexico City, Mexico City, 14080, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Tlalpan, Mexico City, 14080, Mexico

Location

Related Publications (1)

  • Valdes-Ferrer SI, Crispin JC, Belaunzaran-Zamudio PF, Rodriguez-Osorio CA, Cacho-Diaz B, Alcocer-Varela J, Cantu-Brito C, Sierra-Madero J. Add-on Pyridostigmine Enhances CD4+ T-Cell Recovery in HIV-1-Infected Immunological Non-Responders: A Proof-of-Concept Study. Front Immunol. 2017 Oct 18;8:1301. doi: 10.3389/fimmu.2017.01301. eCollection 2017.

    PMID: 29093707DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Carlos Aguilar Salinas, Director of Ethics in Human Research Committee
Organization
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
carlos.aguilars@incmnsz.mx
5554870900

Study Officials

  • Juan Sierra-Madero, MD

    Dept. of Infectious Diseases, INNSZ

    STUDY CHAIR

  • Jorge Alcocer-Varela, MD

    Dept. of Immunology, INNSZ

    STUDY DIRECTOR

  • Sergio I Valdés-Ferrer, MD, PhD

    Dept. of Neurology, INNSZ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator, Depatment of Infectious Diseases

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 20, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

November 14, 2019

Results First Posted

November 14, 2019

Record last verified: 2019-10

Locations

ME(2)