Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: study protocol of a multi-center prospective randomized controlled trial

Table 1 Study enrollment and follow-up schedule, detailing specific interventions and assessments

Time window	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7	Visit 8
Time window	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

ISSN: 1745-6215