Trial reportPloS one2011
A phase I randomized placebo controlled trial of the safety of 3% SPL7013 Gel (VivaGel®) in healthy young women administered twice daily for 14 days.
Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00331032 (An Expanded Phase I Randomized Placebo Controlled Trial of the Safety and Tolerability of 3 Percent w/w SPL7013 Gel), which is not on this map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Expanded Phase I Randomized Placebo Controlled Trial of the Safety and Tolerability of 3 Percent w/w SPL7013 Gel (VivaGel™) in Healthy Young Women When Administered Twice Daily for 14 Days
Who cites it
24 citing papers in PubMed, 74 citations in OpenAlex.
- Measurement of mucosal biomarkers in a phase 1 trial of intravaginal 3% StarPharma LTD 7013 gel (VivaGel) to assess expanded safety.Journal of acquired immune deficiency syndromes (1999) · 2012Trial
- Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).AIDS (London, England) · 2011Trial
- Advances in Dendrimer-Based Anti-Infective Systems: In Vivo Insights and Perspectives.Pharmaceutics · 2026Review
- Challenges in developing broad-spectrum viral attachment inhibitors targeting heparan sulfates and sialic acids.Journal of virology · 2026Review
- Solubilization techniques used for poorly water-soluble drugs.Acta pharmaceutica Sinica. B · 2024Review
- Dendrimers in Corneal Drug Delivery: Recent Developments and Translational Opportunities.Pharmaceutics · 2023Review
- Dendrimer-Mediated Delivery of DNA and RNA Vaccines.Pharmaceutics · 2023Review
- Dendrimers, an Emerging Opportunity in Personalized Medicine?Journal of personalized medicine · 2022Review
- Baseline and time-updated factors in preclinical development of anionic dendrimers as successful anti-HIV-1 vaginal microbicides.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2022Review
- Topical Astodrimer Sodium, a Non-Toxic Polyanionic Dendrimer, Demonstrates Antiviral Activity in an Experimental Ocular Adenovirus Infection Model.Molecules (Basel, Switzerland) · 2021Article
- Peptides and Dendrimers: How to Combat Viral and Bacterial Infections.Pharmaceutics · 2021Review
- Progress in Nanomedicine: Approved and Investigational Nanodrugs.P & T : a peer-reviewed journal for formulary management · 2017Article
- The role of nanotechnology in the treatment of viral infections.Therapeutic advances in infectious disease · 2017Review
- Clinical Translation of Nanomedicine.Chemical reviews · 2015Review
- Thermosensitive Gel Containing Cellulose Acetate Phthalate-Efavirenz Combination Nanoparticles for Prevention of HIV-1 Infection.Journal of biomedical nanotechnology · 2015Article
- Protein and oligonucleotide delivery systems for vaginal microbicides against viral STIs.Cellular and molecular life sciences : CMLS · 2015Review
- Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction.Journal of the International AIDS Society · 2014Article
- A review of nanotechnological approaches for the prophylaxis of HIV/AIDS.Biomaterials · 2013Review
- Dendrimers as potential therapeutic tools in HIV inhibition.Molecules (Basel, Switzerland) · 2013Review
- Methodological lessons from clinical trials and the future of microbicide research.Current HIV/AIDS reports · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
Abstract
objectiveTo assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18-24 years in the USA and Kenya.
designRandomized placebo controlled trial.
methodsParticipants were randomized 2∶1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm.
resultsFifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H₂O₂-producing and non-producing lactobacilli did not differ by study arm.
conclusionsGU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm.
trial registrationClinicalTrials.gov NCT003311032.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.