Effect of HSV-2 Suppressive Therapy on Genital Tract HIV-1 RNA Shedding among Women on HAART: A Pilot Randomized Controlled Trial

Table 1

Baseline demographic and clinical characteristics.

	Acyclovir (𝑁=30)	No acyclovir (𝑁=30)	Overall (𝑁=60)	𝑃 value^2
Age (mean)	45 (25–59)	43 (23–56)	44	0.53
Ethnicity
White	10 (33%)	11 (36%)	21 (35%)	0.43
Black	14 (47%)	9 (30%)	23 (38%)
Hispanic	5 (17%)	6 (20%)	11 (18%)
Other	1 (3%)	4 (13%)	5 (8%)
HIV risk factor
Ever injected drugs	15 (50%)	11 (37%)	26 (43%)	0.42
Ever had sex with male IDU	18 (60%)	20 (67%)	38 (63%)	0.79
Ever had sex with HIV-infected male	17 (57%)	25 (83%)	42 (70%)	0.05
Ever exchanged sex for drugs or money	6 (20%)	9 (30%)	15 (25%)	0.55
>1 HIV risk factor	18 (60%)	21 (70%)	39 (65%)	0.59
Baseline CD4 count: mean (range)	552 (196–1877)	539 (169–1600)	546	0.42
Baseline contraceptives	1 (3%)	0 (0%)	1 (2%)	1.0
HAART at baseline
NRTIs only	2	3	5	1.0
NRTI +NNRTI	15	15	30
NRTI + PI	12	11	23
Other: NNRTI +PI; integrase inhibitor	1	1	2
+ CCR5 inhibitor
Baseline Testing
Chlamydia	0 (0%)	0 (0%)	0 (0%)	1.0
Gonorrhea	0 (0%)	0 (0%)	0 (0%)	1.0
Syphilis	0 (0%)	0 (0%)	0 (0%)	1.0
Trichomonas	0 (0%)	1 (3%)	1 (2%)	1.0
BV	7 (23%)	11 (37%)	18 (30%)	0.40
Semen	2 (7%)	2 (6.7%)	4 (7%)	1.0
Asymptomatic HSV (PCR)	0 (0%)	3 (10%)	3 (5%)	0.24
Detectable baseline Plasma HIV	5 (17%)	2 (7%)	7 (12%)	0.43
Detectable baseline GT HIV^1	3 (10%)	1 (3%)	4 (7%)	0.61

¹One woman in the control arm had invalid baseline GT HIV.
²Categorical variables were tested using Fisher exact test, and continuous variables were tested using Wilcoxon rank sum test.
NOTE. IDU, injection drug user; HAART, highly active antiretroviral therapy; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; NNRTI non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; HSV, herpes simplex virus; PCR, polymerase chain reaction; GT, Genital Tract; BV, bacterial vaginosis.