Trial reportJournal of acquired immune deficiency syndromes (1999)2009
A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 38 citations in OpenAlex.
- 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
- SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans.PloS one · 2011Trial
- Advances in Dendrimer-Based Anti-Infective Systems: In Vivo Insights and Perspectives.Pharmaceutics · 2026Review
- Dendrimer-Mediated Delivery of DNA and RNA Vaccines.Pharmaceutics · 2023Review
- Dendrimers, an Emerging Opportunity in Personalized Medicine?Journal of personalized medicine · 2022Review
- Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro.Antiviral research · 2021Article
- Historical development of vaginal microbicides to prevent sexual transmission of HIV in women: from past failures to future hopes.Drug design, development and therapy · 2017Review
- Review
- Non-specific microbicide product development: then and now.Current HIV research · 2012Review
- Virucidal activity of the dendrimer microbicide SPL7013 against HIV-1.Antiviral research · 2011Article
- Structure activity relationship of dendrimer microbicides with dual action antiviral activity.PloS one · 2010Article
- Advances in the Development of Microbicides for the Prevention of HIV Infection.Current infectious disease reports · 2010Article
- Enhancement of human immunodeficiency virus type 1 replication is not intrinsic to all polyanion-based microbicides.Antimicrobial agents and chemotherapy · 2009Article
- Article
- Attitudes of men in an Australian male tolerance study towards microbicide use.Sexual health · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
Abstract
objectivesTo determine the safety of the candidate vaginal microbicide SPL7013 gel (VivaGel) when applied to the penis.
methodsA randomized, double-blind, placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 uncircumcised) were randomized in a 2:1 ratio and treated with 3% SPL7013 gel (n = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity was determined by interview, diary, and examination.
resultsThere were 10 genital adverse events (AEs) in 6 men (25%) receiving SPL7013 gel and 5 genital AEs in 4 men (33%) receiving the placebo that were possibly or probably related to the study product (difference of -8%, 95% confidence interval: -40% to 23%, P = 0.70). The most common genital AEs were genital pruritus and application site erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group were transient. Analysis of vital signs, nongenital AEs, and laboratory results indicated no safety or tolerability issues with SPL7013 gel, irrespective of circumcision status. There was no detectable absorption of SPL7013 into the plasma.
conclusionsThree percent SPL7013 gel was safe and well tolerated, and comparable with placebo, when administered to the penis of both circumcised and uncircumcised men once daily for 7 days, with no evidence of systemic absorption or toxicity.
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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.