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Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women

NCT02875119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-11-27

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infection

Interventions

DRUG

Griffithsin Gel

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.

DRUG

Placebo Gel

Placebo Gel

Sponsors & Collaborators

  • Population Council

    lead OTHER

Principal Investigators

  • George Creasy, MD · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-07-31
Completion
2018-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875119 on ClinicalTrials.gov