| Time window | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 |
|---|---|---|---|---|---|---|---|---|
|
Screen − 28 to 0 days |
Baseline 0 day | 4 weeks±14 days | 8 weeks±14 days | 12 weeks±14 days | 24 weeks±14 days | 36 weeks±14 days | 48 weeks±14 days | |
| Sign informed consent | X | |||||||
| Inclusion and exclusion criteria | X | |||||||
| Demography | X | |||||||
| Signs and symptoms | X | X | X | X | X | X | X | |
| HIV screening | X | |||||||
| HIV confirmation | X | |||||||
| Hematological analysis | X | X | X | X | X | X | X | |
| Urinalysis | X | |||||||
| Clinical chemistry studies | X | X | X | X | X | X | X | |
| Blood CMV antibodies IgG/IgM | X | X | X | |||||
| Blood/aqueous or vitreous CMV DNA | X | X | X | X | X | X | ||
| Urine pregnancy test | X | |||||||
| Lymphocyte subset | X | X | X | X | X | X | ||
| Quantitative plasma HIV-1 RNA | X | X | X | |||||
| Electrocardiogram | X | |||||||
| Ophthalmological examination | X | X | X | X | X | X | ||
| IRU | X | X | X | X | X | X | ||
| Therapeutic regimens (anti-CMV and ART) | X | X | X | X | X | X | X | X |
| Concomitant medications | X | X | X | X | X | X | X | |
| Adverse events | X | X | X | X | X | X | X |