Trial reportJournal of acquired immune deficiency syndromes (1999)2016
First-in-Human Trial of MIV-150 and Zinc Acetate Coformulated in a Carrageenan Gel: Safety, Pharmacokinetics, Acceptability, Adherence, and Pharmacodynamics.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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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
20 citing papers in PubMed.
- Development and characterization of formulations based on combinatorial potential of antivirals against genital herpes.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Efficacy and safety of a self-applied carrageenan-based gel to prevent human papillomavirus infection in sexually active young women (CATCH study): an exploratory phase IIB randomised, placebo-controlled trial.EClinicalMedicine · 2023Article
- A Brief History and Advancement of Contraceptive Multipurpose Prevention Technology (cMPT) Products.Open access journal of contraception · 2023Review
- Zinc and Zinc Transporters in Dermatology.International journal of molecular sciences · 2022Review
- Acceptability of PC-1005 Gel Administered Rectally to HIV-1 Seronegative Adults at Three Different Volume Levels (MTN-037).AIDS education and prevention : official publication of the International Society for AIDS Education · 2022Article
- Approved HIV reverse transcriptase inhibitors in the past decade.Acta pharmaceutica Sinica. B · 2022Review
- Griffithsin and Carrageenan Combination Results in Antiviral Synergy against SARS-CoV-1 and 2 in a Pseudoviral Model.Marine drugs · 2021Article
- Recent Advances in Polymer-Based Vaginal Drug Delivery Systems.Pharmaceutics · 2021Review
- Inductively coupled plasma mass spectrometry method for plasma and intracellular antimony quantification applied to pharmacokinetics of meglumine antimoniate.Bioanalysis · 2021Article
- Understanding the relationship between viral infections and trace elements from a metallomics perspective: implications for COVID-19.Metallomics : integrated biometal science · 2020Review
- Carrageenans as Broad-Spectrum Microbicides: Current Status and Challenges.Marine drugs · 2020Review
- Adenovirus vector-based prime-boost vaccination via heterologous routes induces cervicovaginal CD8International journal of cancer · 2018Article
- Future of nonnucleoside reverse transcriptase inhibitors.Proceedings of the National Academy of Sciences of the United States of America · 2018Article
- On-demand microbicide products: design matters.Drug delivery and translational research · 2017Review
- MIV-150 and zinc acetate combination provides potent and broad activity against HIV-1.Drug delivery and translational research · 2017Article
- Article
- MZC Gel Inhibits SHIV-RT and HSV-2 in Macaque Vaginal Mucosa and SHIV-RT in Rectal Mucosa.Journal of acquired immune deficiency syndromes (1999) · 2017Article
- 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
- In Vitro Exposure to PC-1005 and Cervicovaginal Lavage Fluid from Women Vaginally Administered PC-1005 Inhibits HIV-1 and HSV-2 Infection in Human Cervical Mucosa.Antimicrobial agents and chemotherapy · 2016Article
- A Novel Microbicide/Contraceptive Intravaginal Ring Protects Macaque Genital Mucosa against SHIV-RT Infection Ex Vivo.PloS one · 2016Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and pharmacokinetics of MIV-150 and zinc acetate in a carrageenan gel (PC-1005). Acceptability, adherence, and pharmacodynamics were also explored.
designA 3-day open-label safety run-in (n = 5) preceded a placebo-controlled, double-blind trial in healthy, HIV-negative, abstinent women randomized (4:1) to vaginally apply 4 mL of PC-1005 or placebo once daily for 14 days.
methodsAssessments included physical examinations, safety labs, colposcopy, biopsies, cervicovaginal lavages (CVLs), and behavioral questionnaires. MIV-150 (plasma, CVL, tissue), zinc (plasma, CVL), and carrageenan (CVL) concentrations were determined with LC-MS/MS, ICP-MS, and ELISA, respectively. CVL antiviral activity was measured using cell-based assays. Safety, acceptability, and adherence were analyzed descriptively. Pharmacokinetic parameters were calculated using noncompartmental techniques and actual sampling times. CVL antiviral EC50 values were calculated using a dose-response inhibition analysis.
resultsParticipants (n = 20) ranged from 19-44 years old; 52% were black or African American. Among those completing the trial (13/17, PC-1005; 3/3, placebo), 11/17 reported liking the gel overall; 7 recommended reducing the volume. Adverse events, which were primarily mild and/or unrelated, were comparable between groups. Low systemic MIV-150 levels were observed, without accumulation. Plasma zinc levels were unchanged from baseline. Seven of seven CVLs collected 4-hour postdose demonstrated antiviral (HIV, human papillomavirus) activity. High baseline CVL anti-herpes-simplex virus type-2 (HSV-2) activity precluded assessment of postdose activity.
conclusionsPC-1005 used vaginally for 14 days was well tolerated. Low systemic levels of MIV-150 were observed. Plasma zinc levels were unchanged. Postdose CVLs had anti-HIV and anti-human papillomavirus activity. These data warrant further development of PC-1005 for HIV and sexually transmitted infection prevention.
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