Table 1.

Baseline characteristics

Cohort 1Cohort 2Cohort 3Cohort 4
Open-labelOpen-labelRandomized, double-blindedOpen-label
GTL001 100 μg solution + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + placeboPlacebo injection + imiquimodGTL001 600 μg powder + imiquimod
CharacteristicN = 5N = 5N = 14N = 7N = 7N = 9
Mean age ± SD (y)29.0 ± 8.929.8 ± 3.133.1 ± 6.533.3 ± 10.232.7 ± 8.733.2 ± 7.6
Race
 Caucasian5 (100.0)4 (80.0)14 (100.0)7 (100.0)7 (100.0)9 (100.0)
 Other0 (0.0)1 (20.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
HPV type, n (%)
 HPV165 (100.0)4 (80.0)11 (78.6)5 (71.4)5 (71.4)6 (66.7)
 HPV180 (0.0)1 (20.0)3 (21.4)2 (28.6)2 (28.6)3 (33.3)
Co-infection with other HPV types, n (%)1 (20.0)1 (20.0)5 (35.7)0 (0.0)1 (14.3)2 (22.2)
Mean duration of infection (mo)a
 HPV1619.86.514.612.215.413.7
 HPV183.515.310.03.525.7
Cytology at baselineb, n (%)
 Negative (NILM)5 (100.0)5 (100.0)14 (100.0)7 (100.0)7 (100.0)9 (100.0)
 Other0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Previous cytologyb (past 5 years), n (%)
 Negative (NILM)2 (40.0)3 (60.0)7 (50.0)2 (28.6)4 (57.1)4 (44.4)
 ASC-US3 (60.0)0 (0.0)5 (35.7)1 (14.3)0 (0.0)1 (11.1)
 LSIL0 (0.0)2 (40.0)2 (14.3)2 (28.6)2 (28.6)3 (33.3)
 HSIL0 (0.0)0 (0.0)0 (0.0)2 (28.6)0 (0.0)0 (0.0)
  • NOTE: Values are for the safety population.

  • aNumber of months between the earliest recorded relevant positive result and the first study visit with no intervening negative results.

  • bGraded according to the Bethesda system (21). Categories include: atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells of undetermined significance—cannot exclude high-grade squamous intraepithelial lesion (ASC-H), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma, and atypical glandular cells (AGC).