NCT00740584 is a Phase 1/Phase 2 clinical trial of 3% SPL7013 Gel (VivaGel) in HIV Infections, sponsored by Starpharma Pty Ltd.

Who is sponsoring NCT00740584?

NCT00740584 is sponsored by Starpharma Pty Ltd.

What drugs are being tested in NCT00740584?

Interventions in NCT00740584: 3% SPL7013 Gel (VivaGel).

What condition does NCT00740584 study?

NCT00740584 studies HIV Infections, HSV-2 Genital Herpes.

Is NCT00740584 still recruiting?

NCT00740584 is currently completed. Last updated 1 October 2018.

Are results published for NCT00740584?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-10-01 · How we verify

NCT00740584

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers

Completed Phase 1/Phase 2 Results posted Last updated 1 October 2018

What this trial tests

Phase 1/Phase 2 trial testing 3% SPL7013 Gel (VivaGel) in HIV Infections in 12 participants. Completed in 1 March 2009.

Timeline

1 August 2008

Primary endpoint
1 March 2009

1 March 2009

Quick facts

Lead sponsor	Starpharma Pty Ltd
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 August 2008
Primary completion	1 March 2009
Estimated completion	1 March 2009
Sites	1 location across Australia

Drugs / interventions tested

3% SPL7013 Gel (VivaGel) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →
HSV-2 Genital Herpes — all drugs for HSV-2 Genital Herpes →

Sponsor

Starpharma Pty Ltd — full company profile →

Who can join

Adults 18 to 45, female only, with HIV Infections or HSV-2 Genital Herpes. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
Time frame: at 3 hours
The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has.

Sponsor's own description

To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.

Publications & conference data

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

The role of nanotechnology in the treatment of viral infections.
Singh L, Kruger HG, Maguire GEM, Govender T, et al · · 2017 · cited 170× · PMID 28748089 · DOI 10.1177/2049936117713593
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans.
Price CF, Tyssen D, Sonza S, Davie A, et al · · 2011 · cited 97× · PMID 21935377 · DOI 10.1371/journal.pone.0024095
Dendrimers, an Emerging Opportunity in Personalized Medicine?
Caminade AM. · · 2022 · cited 39× · PMID 36013283 · DOI 10.3390/jpm12081334
Dendrimer-Mediated Delivery of DNA and RNA Vaccines.
Kisakova LA, Apartsin EK, Nizolenko LF, Karpenko LI. · · 2023 · cited 29× · PMID 37111593 · DOI 10.3390/pharmaceutics15041106
Controlling the HIV/AIDS epidemic: current status and global challenges.
Demberg T, Robert-Guroff M. · · 2012 · cited 18× · PMID 22912636 · DOI 10.3389/fimmu.2012.00250
Recent Advances in Nanoparticle-Based Antiretroviral Drug Delivery Systems for HIV Treatment and Prevention: A Comprehensive Review.
Das G, Shin HS, Patra JK. · · 2025 · PMID 41287764 · DOI 10.2147/ijn.s540578

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Starpharma Pty Ltd trials

Trials by the same sponsor.

NCT02237950 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT02236156 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT01577537 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed
NCT01577238 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00740584 (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 Starpharma Pty Ltd
Last refreshed: 1 October 2018

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/NCT00740584.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing