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NCT04032717: PREVENT

Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)

Terminated Phase 1 Last updated 6 July 2023
What this trial tests

Phase 1 trial testing Q-Griffithsin (Q-GRFT) enema in HIV Prevention in 18 participants. Terminated before completion.

Timeline
10 July 2019
Primary endpoint
4 February 2021
4 February 2021

Quick facts

Lead sponsorRhonda Brand
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment18
Start date10 July 2019
Primary completion4 February 2021
Estimated completion4 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rhonda Brand — full company profile →

Who can join

Adults 18 to 45, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse.

Publications & conference data

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

  1. Phytopharmaceuticals mediated Furin and TMPRSS2 receptor blocking: can it be a potential therapeutic option for Covid-19?
    Palit P, Chattopadhyay D, Thomas S, Kundu A, et al · · 2021 · cited 20× · PMID 33380375 · DOI 10.1016/j.phymed.2020.153396
  2. Novel Antifungal Activity of Q-Griffithsin, a Broad-Spectrum Antiviral Lectin.
    Nabeta HW, Kouokam JC, Lasnik AB, Fuqua JL, et al · · 2021 · cited 14× · PMID 34494857 · DOI 10.1128/spectrum.00957-21
  3. An algal lectin griffithsin inhibits Hantaan virus infection <i>in vitro</i> and <i>in vivo</i>.
    Zhao Y, Zhao N, Cai Y, Zhang H, et al · · 2022 · cited 10× · PMID 36579342 · DOI 10.3389/fcimb.2022.881083
  4. Women for science and science for women: Gaps, challenges and opportunities towards optimizing pre-exposure prophylaxis for HIV-1 prevention.
    Karim QA, Archary D, Barré-Sinoussi F, Broliden K, et al · · 2022 · cited 10× · PMID 36561760 · DOI 10.3389/fimmu.2022.1055042
  5. HIV-1 Entry and Prospects for Protecting against Infection.
    Bruxelle JF, Trattnig N, Mureithi MW, Landais E, et al · · 2021 · cited 10× · PMID 33499233 · DOI 10.3390/microorganisms9020228
  6. &lt;i&gt;In vitro&lt;/i&gt; Inhibition of HIV-1 by Cyclotide-Enriched Extracts of &lt;i&gt;Viola tricolor&lt;/i&gt;.
    Conzelmann C, Muratspahić E, Tomašević N, Münch J, et al · · 2022 · cited 9× · PMID 35712712 · DOI 10.3389/fphar.2022.888961
  7. Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture.
    Shrivastava-Ranjan P, Lo MK, Chatterjee P, Flint M, et al · · 2020 · cited 9× · PMID 33251157 · DOI 10.3389/fcimb.2020.561502
  8. The Need for Ocular Protection for Health Care Workers During SARS-CoV-2 Outbreak and a Hypothesis for a Potential Personal Protective Equipment.
    Wang L, Deng Y. · · 2020 · cited 6× · PMID 33282819 · DOI 10.3389/fpubh.2020.599757

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Other recruiting trials for HIV Prevention

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