HIV-MSM vaccine (n = 66) | HIV-MSM placebo (n = 63) | p* | |
---|---|---|---|
Age, years; mean (±SD) | 37.3 (±10.6) | 40.5 (±10.02) | 0.082 |
Spanish nationality, n (%) | 63 (95.5) | 60 (95.2) | 0.2 |
University education, n (%) | 34 (51.5) | 35 (55.5) | 0.56 |
Partners in the previous 12 months; median (IQR) | 1 (1–3) | 1 (1–5) | 0.8 |
Life-time partners; n, median (IQR) | 50 (20–300) | 100 (45–350) | 0.041* |
Years of sexual activity; median (IQR) | 17 (9–24) | 21 (13–27) | 0.025* |
Condom use, n (%) | 53 (80.3) | 47 (74.6) | 0.4 |
Perianal/genital condylomas at screening, n (%) | 20 (30.3) | 20 (31.7) | 0.86 |
History of condylomas, n (%) | 19 (28.8) | 15 (23.8) | 0.52 |
Duration of HIV; mean months (IQR) | 58 (26–120) | 77 (37–138) | 0.2 |
History of AIDS; n (%) | 19 (28.8) | 21 (33.3) | 0.58 |
CD4 mean nadir; cells/µL, (±SD) | 336 (±227.3) | 334.2 (±193.7) | 0.96 |
CD4 mean; cells/µL (±SD) | 733 (±252.7) | 710.4 (±266.6) | 0.62 |
CD8 mean; cells/µL (±SD) | 999.9 (±463.6) | 992.2 (±374.9) | 0.98 |
VL of HIV log10; copies/mL (±SD) | 3.76 (±4.5) | 3.67 (±4.46) | 0.8 |
VL <50 copies/mL, n (%) | 53 (80.3) | 53 (84.1) | 0.57 |
Virological failure, n (%) | 1 (1.5) | 3 (4.8) | 0.29 |
Median duration of ART; months (IQR) | 42 (17–86) | 43 (17–129) | 0.42 |
Number of lines of ART, median (IQR) | 1 (1–2) | 1 (1–2) | 0.56 |
Syphilis treated, n (%) | 16 (24.2) | 12 (19.1) | 0.47 |
Other STD, n (%) | 11 (16.6) | 12 (19.1) | 0.72 |
Latent tuberculosis treated, n (%) | 5 (7.6) | 10 (15.9) | 0.14 |
HCV, n (%) | 2 (3) | 2 (3.2) | 1 |
HBV, n (%) | 2 (3) | 0 (0) | 0.49 |
Smoking, packets/year, median (IQR) | 0.2 (0–1) | 6.5 (0–18) | 0.008* |
Ex-smoking, n (%) | 10 (15) | 13 (20.6) | 0.0.42 |
Ex-IVDA, n (%) | 1 (1.5) | 0 (0) | 0.42 |
Alcohol (standard units of alcohol; SUA) | 0 (0–1) | 0.4 (0–1.4) | 0.15 |