This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
15
Griffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
Placebo Gel
Albert Einstein College of Medicine
The Bronx, New York, United States
Number and percent of participants with TEAEs, SAEs and AEs leading to premature discontinuation.
To evaluate the safety of PC-6500 gel used vaginally for a single dose; and then for 14 consecutive days of dosing. AEs will be coded in accordance with the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: 10 months
Evaluation of the area under the time-concentration curve of Griffithsin gel in blood during and after dosing as assessed by (AUC0-last; AUC0-∞)
To determine the PK of Griffithsin Gel in blood after a single dose, and then after 14 days of dosing.
Time frame: 10 months
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