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NCT04032717: PREVENT
Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)
Phase 1 trial testing Q-Griffithsin (Q-GRFT) enema in HIV Prevention in 18 participants. Terminated before completion.
4 February 2021
Quick facts
| Lead sponsor | Rhonda Brand |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 18 |
| Start date | 10 July 2019 |
| Primary completion | 4 February 2021 |
| Estimated completion | 4 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Q-Griffithsin (Q-GRFT) enema — full drug profile →
- Placebo enema
Conditions studied
- HIV Prevention — all drugs for HIV Prevention →
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):
-
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 -
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 -
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 -
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 -
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 -
<i>In vitro</i> Inhibition of HIV-1 by Cyclotide-Enriched Extracts of <i>Viola tricolor</i>.
Conzelmann C, Muratspahić E, Tomašević N, Münch J, et al · · 2022 · cited 9× · PMID 35712712 · DOI 10.3389/fphar.2022.888961 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04032717
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Rhonda Brand trials
Trials by the same sponsor.
- NCT04302896 — Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04032717 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rhonda Brand
- Last refreshed: 6 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04032717.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing