Acceptability of UC781 Gel as a Rectal Microbicide Among HIV-Uninfected Women and Men

Ventuneac, Ana; Carballo‐Diéguez, Alex; McGowan, Ian; Dennis, R; Adler, Amy; Khanukhova, Elena; Price, Charles; Saunders, Terry; Siboliban, Chomchay; Anton, Peter A.

doi:10.1007/s10461-009-9611-5

Cited by 36 publications

(38 citation statements)

References 37 publications

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“…Findings from numerous studies and small Phase I trials suggest both placebo (Carballo-Dieguez et al, 2008; Carballo-Dieguez, Exner, et al, 2007; Pines et al, 2013) and anti-retroviral containing (Anton et al, 2012; McGowan et al, 2013; Ventuneac et al, 2010) rectal microbicide products are safe and acceptable. Phase II trials are now underway to assess the safety, acceptability, and pharmacodynamics of various rectal microbicide gel formulations (McGowan, 2014).…”

Section: Introductionmentioning

confidence: 99%

Commercial lubricant use among HIV-negative men who have sex with men in Los Angeles: implications for the development of rectal microbicides for HIV prevention

et al. 2014

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To inform the development and assess potential use of rectal microbicide gels for HIV prevention among men who have sex with men (MSM), we examined the dynamics and contexts of commercial lubricant use during receptive anal intercourse (RAI) within this population. From 2007–2010, 168 HIV-negative MSM living in Los Angeles who practice RAI completed computer-assisted self-interviews, which collected information on their last sexual event with ≤3 recent partners, at baseline, 3 months, and 1 year study visits. Logistic generalized linear mixed models were used to identify individual- and sexual event-level characteristics associated with commercial lubricant use during RAI at the last sexual event within 421 partnerships reported by participants over the course of follow-up. During RAI at their last sexual event, 57% of partnerships used a condom and 69% used commercial lubricant. Among partnerships that used commercial lubricant, 56% reported lubricant application by both members of the partnership, 66% first applied lubricant during sex, but before penetration, and 98% applied lubricant at multiple locations. The relationship between substance use and commercial lubricant use varied by condom use (interaction p-value=0.01). Substance use was positively associated with commercial lubricant use within partnerships that used condoms during RAI at their last sexual event (adjusted odds ratio [AOR]=4.47, 95% confidence interval [CI]: 1.63–12.28), but no association was observed within partnerships that did not use condoms (AOR=0.66, 95% CI: 0.23–1.85). Commercial lubricant use during RAI was also positively associated with reporting more sexual partners (AOR=1.18, 95% CI: 1.05–1.31), while older age (units= 5 years) (AOR=0.75, 95% CI: 0.61–0.94), homelessness (past year) (AOR=0.32, 95% CI: 0.13–0.76), and having sex with an older (>10 years) partner (AOR=0.37, 95% CI: 0.14–0.95) were negatively associated with commercial lubricant use. These factors should be considered in the development of rectal microbicide gels to enhance their acceptability and use among MSM.

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Section: Introductionmentioning

confidence: 99%

Commercial lubricant use among HIV-negative men who have sex with men in Los Angeles: implications for the development of rectal microbicides for HIV prevention

et al. 2014

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“…Aside from a number of studies designed to investigate the behavior of placebo products in the rectum, a few studies have evaluated rectally applied microbicide products contacting antiretrovirals. These studies are focused on the drug safety and acceptability evaluation for rectal use, such as of tenofovir gel (McGowan et al 2013) and UC781 (Ventuneac et al 2010). …”

Section: Microbicide Productsmentioning

confidence: 99%

Microbicide Dosage Forms

Rohan

Devlin

Yang

2013

Current Topics in Microbiology and Immunology

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Microbicides are topically applied, user controlled dosage forms that are being developed to prevent the transmission of HIV during coitus. Early candidates focused on coitally dependent dosage forms such as gels and creams. More recent development has focused on broadening the coitally dependent options through the introduction of films and fast dissolving tablets. Additionally, it has become important to have longer acting products to minimize the burden of user compliance and thus vaginal rings have been developed providing sustained delivery of antiretroviral drugs. This chapter discusses the history of microbicides along with a detailed description of coitally dependent products, gels, films, tablets diaphragms, as well as coitally independent dosage forms such as vaginal rings and the introduction of a new technology, electrospun fibers.

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“…Vaginal candidate UC781 (Conrad, Arlington, Virginia, USA), an NNRTI, was tested for acceptability among HIV-1-uninfected adults [48 ]. The phase I blinded, placebo-controlled trial enrolled 10 women and 26 men into three groups of 12, randomized to receive 0.1% UC781 gel, 0.25% UC781 gel or a placebo gel (hydroxyethyl cellulose).…”

Section: Rectal Microbicidesmentioning

confidence: 99%