NCT02875119

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

Completed Phase 1 Last updated 27 November 2018

What this trial tests

Phase 1 trial testing Griffithsin Gel in HIV Infection in 15 participants. Completed in 1 September 2018.

Timeline

1 October 2017

Primary endpoint
31 July 2018

1 September 2018

Quick facts

Lead sponsor	Population Council
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	15
Start date	1 October 2017
Primary completion	31 July 2018
Estimated completion	1 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Griffithsin Gel — full drug profile →
• Placebo Gel

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Population Council

Who can join

Adults 18 to 49, female only, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The glycosylation in SARS-CoV-2 and its receptor ACE2.
   Gong Y, Qin S, Dai L, Tian Z. · · 2021 · cited 175× · PMID 34782609 · DOI 10.1038/s41392-021-00809-8
2. Marine Natural Products in Clinical Use.
   Haque N, Parveen S, Tang T, Wei J, et al · · 2022 · cited 101× · PMID 36005531 · DOI 10.3390/md20080528
3. Griffithsin carrageenan fast dissolving inserts prevent SHIV HSV-2 and HPV infections in vivo.
   Derby N, Lal M, Aravantinou M, Kizima L, et al · · 2018 · cited 58× · PMID 30250170 · DOI 10.1038/s41467-018-06349-0
4. Antiviral Strategies Using Natural Source-Derived Sulfated Polysaccharides in the Light of the COVID-19 Pandemic and Major Human Pathogenic Viruses.
   Ray B, Ali I, Jana S, Mukherjee S, et al · · 2021 · cited 38× · PMID 35062238 · DOI 10.3390/v14010035
5. Delivery of biologics: Topical administration.
   Kulchar RJ, Singh R, Ding S, Alexander E, et al · · 2023 · cited 31× · PMID 37690380 · DOI 10.1016/j.biomaterials.2023.122312
6. Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel.
   Teleshova N, Keller MJ, Fernández Romero JA, Friedland BA, et al · · 2022 · cited 29× · PMID 35051209 · DOI 10.1371/journal.pone.0261775
7. Topical Inserts: A Versatile Delivery Form for HIV Prevention.
   Peet MM, Agrahari V, Anderson SM, Hanif H, et al · · 2019 · cited 27× · PMID 31374941 · DOI 10.3390/pharmaceutics11080374
8. On-demand microbicide products: design matters.
   Patel SK, Rohan LC. · · 2017 · cited 20× · PMID 28589452 · DOI 10.1007/s13346-017-0385-4