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 |