Table 4.
Screening | Week 0 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | 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 | 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 | |||
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 |
1If syphilis test is positive at screening, participants will be retested at weeks 24 and 48.
2HIV viral load testing will be performed as indicated by treating physician.
3Participants will start ER niacin administration after their week 24 visit.
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.
5SMAQ, Simple Medication Adherence Questionnaire.