Trial Outcomes & Findings for Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response (NCT NCT00518154)
NCT ID: NCT00518154
Last Updated: 2019-11-14
Results Overview
Change in total CD4+ T-cell number from baseline to addition of pyridostigmine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
16 weeks after initiation of pyridostigmine
Results posted on
2019-11-14
Participant Flow
Participant milestones
| Measure |
Pyridostigmine
Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment. The study is open-label, proof-of-concept.
Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response
Baseline characteristics by cohort
| Measure |
Change in Circulating CD4+ T-cell Count (Baseline vs. 16 Weeks
n=7 Participants
Participants will receive pyridostigmine 30mg three times per day for a period of 16 weeks. Pyridostigmine will be in addition (add-on) to their usual antiretroviral treatment schedule.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after initiation of pyridostigminePopulation: Change in total CD4+ T-cell counts
Change in total CD4+ T-cell number from baseline to addition of pyridostigmine
Outcome measures
| Measure |
Pyridostigmine
n=7 Participants
Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment. The study is open-label, proof-of-concept.
Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks
|
|---|---|
|
CD4+ Cell Count Change Between Basal and Week 16 of Additive Treatment
|
153.2 CD4+ T-cell count/uL
Standard Deviation 43.1
|
Adverse Events
Pyridostigmine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carlos Aguilar Salinas, Director of Ethics in Human Research Committee
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Phone: 5554870900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place