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Table 3 Visit schedule, arm 1

From: The role of extended-release niacin on immune activation and neurocognition in HIV-infected patients treated with antiretroviral therapy – CTN PT006: study protocol for a randomized controlled trial

 

Screening

Week 0

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

Week 48 (final visit)

Visit number

V1

V2

V3

V4

V5

V6

V7

V8

V9

Consent form

X

        

Medical history

X

        

Dietary survey

 

X

       

Physical exam and vital signs

X

X

X

X

X

X

X

X

X

Adverse events

 

X

X

X

X

X

X

X

X

Hematology

X

X

X

X

X

X

X

X

X

Chemistry

X

X

X

X

X

X

X

X

X

Pregnancy test (women only)

X

        

Hepatitis B and C tests

X

        

ART review

X

        

Syphilis test1

X

      

X

X

T-cell activation and inflammatory markers

 

X

     

X

X

HIV viral load2

X

   

X

  

X

X

Levels of tryptophan, niacin and its derivatives

 

X

 

X

 

X

 

X

X

ER niacin admin3

 

X

X

X

X

X

X

X

 

Bays-Ballantyne questionnaire

  

X

X

X

X

X

X

 

WHOQOL-HIV BREF, CES-D, POMS, HVLT-R™, and CANTAB™ tests4

 

X

     

X

X

SMAQ5

 

X

  

X

  

X

X

  1. 1If Syphilis test is positive at screening, participants will be retested at weeks 24 and 48.
  2. 2HIV viral load testing will be performed as indicated by treating physician.
  3. 3Participants will end ER niacin administration at the end of week 24.
  4. 4Neurocognitive assessments are optional; WHOQOL-HIV BREF, World Health Organization quality of life instrument in patients with HIV infection-brief; CES-D, Center for Epidemiologic Studies Depression Scale; POMS, Profile of Mood State; HVLT-R™, Hopkins Verbal Learning Test Revised; CANTAB, Cambridge Neuropsychological Test Automated Battery.
  5. 5SMAQ, Simple Medication Adherence Questionnaire.