Dataset Information

Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse.

ABSTRACT:

Background

Microbicide toxicity may reduce the efficacy of topical preexposure prophylaxis for human immunodeficiency virus (HIV) transmission. Noninvasive quantitative measures of microbicide toxicity would usefully inform microbicide development.

Methods

Ten subjects received 3 one-time interventions: 5 mL of Normosol-R fluid alone (negative control), 5 mL of 2% nonoxynol-9 (N-9) gel, and 5 mL of Normosol-R with coital simulation and sigmoidoscopic biopsy (CS + BX). Each dose of N-9 and Normosol-R contained 500 µCi of (99m)technetium-diethylene triamine pentaacetic acid. Plasma and urine radioactivity was assessed over 24 hours.

Results

The plasma radioisotope concentration peaked 1 hour after N-9 dosing. The mean maximum radioisotope concentration after N-9 receipt was 12.0 times (95% confidence interval [CI], 6.8-21.0) and 8.4 times (95% CI, 5.2-13.5) the mean concentration after Normosol-R control receipt and CS + BX receipt, respectively; paired differences persisted for 24 hours. After N-9 dosing, the urine isotope level was 3.6 times (95% CI, 1.1-11.4) the level observed 8 hours after Normosol-R control receipt and 4.0 times (95% CI, 1.4-11.4) the level observed 4 hours after CS + BX receipt. Permeability after CS + BX receipt was greater than that after Normosol-R control receipt in 0-2-hour urine specimens only (mean permeability, 2.4; 95% CI, 1.0-5.8) but was not greater in blood.

Conclusions

Plasma sampling after rectal radioisotope administration provided quantitative estimates of altered mucosal permeability after chemical and mechanical stresses. Permeability testing may provide a useful noninvasive adjunct to assess the mucosal effects of candidate microbicides. Clinical Trials Registration. NCT00389311.

SUBMITTER: Fuchs EJ

PROVIDER: S-EPMC3693591 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Publications

Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse.

Fuchs Edward J EJ Grohskopf Lisa A LA Lee Linda A LA Bakshi Rahul P RP Hendrix Craig W CW

The Journal of infectious diseases 20130116 9

<h4>Background</h4>Microbicide toxicity may reduce the efficacy of topical preexposure prophylaxis for human immunodeficiency virus (HIV) transmission. Noninvasive quantitative measures of microbicide toxicity would usefully inform microbicide development.<h4>Methods</h4>Ten subjects received 3 one-time interventions: 5 mL of Normosol-R fluid alone (negative control), 5 mL of 2% nonoxynol-9 (N-9) gel, and 5 mL of Normosol-R with coital simulation and sigmoidoscopic biopsy (CS + BX). Each dose of ...[more]

PMID: 23325915

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Project description:BackgroundRectal products used with anal intercourse (AI) may facilitate transmission of STIs/HIV. However, there is limited data on rectal douching behavior in populations practicing AI. We examined the content, types of products, rectal douching practices and risk behaviors among those reporting AI.MethodsFrom August 2011 to May 2012, 1,725 women and men reporting receptive AI in the past 3 months completed an internet-based survey on rectal douching practices. The survey was available in English, French, German, Mandarin, Portuguese, Russian, Spanish, and Thai and included questions on sexual behaviors associated with AI including rectal douching. Differences by rectal douching practices were evaluated using chi-square methods and associations between reported douching practices and other factors including age and reported STI history were evaluated using logistic regression analysis.ResultsRespondents represented 112 countries, were mostly male (88%), and from North America (55%) or Europe (22%). Among the 1,339 respondents (66%) who reported rectal douching, most (83%) reported always/almost always douching before receptive AI. The majority of rectal douchers reported using non-commercial/homemade products (93%), with water being the most commonly used product (82%). Commercial products were used by 31%, with the most common product being saline-based (56%). Rectal douching varied by demographic and risk behaviors. The prevalence of rectal douching was higher among men (70% vs. 32%; p-value < .01), those reporting substance-use with sex (74% vs. 46%; p-value < .01), and those reporting an STI in the past year (69% vs. 57% p-value < .01) or ever testing HIV-positive (72% vs. 53%; p-value < .01). In multivariable analysis, adjusting for age, gender, region, condom and lubricant use, substance use, and HIV-status, douchers had a 74% increased odds of reporting STI in the past year as compared to non-douchers [adjusted odds ratio (AOR) = 1.74; 95% CI 1.01-3.00].ConclusionGiven that rectal douching before receptive AI is common and because rectal douching was associated with other sexual risk behaviors the contribution of this practice to the transmission and acquisition of STIs including HIV may be important.

Dataset Information

Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse.

Background

Methods

Results

Conclusions

Publications

Quantitative assessment of altered rectal mucosal permeability due to rectally applied nonoxynol-9, biopsy, and simulated intercourse.

Similar Datasets

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