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A randomized six-day safety study of an antiretroviral microbicide candidate UC781, a non-nucleoside reverse transcriptase inhibitor

, : A randomized six-day safety study of an antiretroviral microbicide candidate UC781, a non-nucleoside reverse transcriptase inhibitor. Sexually Transmitted Diseases 35(4): 414-419

Goal: This study evaluated the effect of a single dose and 5 additional consecutive daily doses of UC781 gel at concentrations of 0.1% 0.25%, 1.0%, and 0% on urogenital irritation.Study Design: Forty-eight healthy sexually abstinent women were randomly assigned to 1 of 4 groups.Methods: Urogenital irritation was assessed by pelvic examination, colposcopy, and reports of genital symptoms at baseline and after 1 and 6 doses. Vaginal health was assessed by wet mount and systemic safety by laboratory evaluation after 1 and 6 doses, and UC781 levels were assessed at baseline and after 6 doses.Results: Some evidence of urogenital irritation was common in all treatment groups and was most often transient and mild. Colposcopic findings were infrequent in the placebo group (8%) and more common in the 3 treatment groups (24%-42%). Edema, which may indicate underlying inflammation, was observed in the vaginal fornix of 2 women exposed to UC781. There was no apparent increase in vaginal infection or clinically significant changes in laboratory values. Two of 12 participants randomized to 1% UC781 gel had detectable plasma levels that were less than the lower level of quantification.Conclusions: UC781 was well tolerated in this initial dose ranging safety study when used once daily for 6 days in sexually abstinent women. Five safety/pharmacokinetic studies of UC781 are currently underway in women and men, all utilizing UC781 concentrations less than 1%, with twice-daily dosing in some studies, and all involving careful monitoring of exposed epithelium.


PMID: 18362865

DOI: 10.1097/OLQ.0b013e318162c4d8

Other references

Pawlak, J., 2001: Problematics of animal production mechanization at the XXIX CIOSTA congress. This paper summarizes the output of the XXIX congress of the International Commission of Work Study and Labour Management in Agriculture (CIOSTA). Topics covered include: improvements in milk yield and quality of dairy cows, labour inputs, manure...

Seeley., 1898: On large terrestrial Saurians from the Rhaetic Beds of Wedmore Hill, described as Avalonia sanfordi and Picrodon herveyi. Geological Magazine, (iv)(v): 1-6

Djiane, J.K.nn, G., 1975: Prolactin like hormone in ovine placenta: its lactogenic activity. measurement of its levels during pregnancy. Comptes rendus hebdomadaires des seances Serie D Sciences naturelles: 3, 280 (24) 2785-2788

Petrov, N., 1926: Les protozoaires du sang dans le typhus exanthematique. Compte Rendu des Seances de la Societe de Biologie Paris, 95: 1569 & 1570

McKenzie, K.G. ., 1987: Shallow Tethys 2. Proceedings of the International Symposium on Shallow Tethys 2, Wagga Wagga, 15-17 September 1986. Unknown

Stricker, B.H.; Ottervanger, J.P.; van der Klauw, M.M., 1994: Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993. In 1993, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 1585 reports of suspected adverse reactions. The most important reports concerned myocardial infarction due to sumatriptan, cholestatic hepatitis due to itracona...

Ulman, J.; Ulman-Doniec, I.; Hereda-Kubica, M., 1987: Hyperthermia in early pregnancy as a possible teratogenic factor. Wiadomosci Lekarskie 40(2): 106-110

Akiyama, J.; Kato, S.; Tsubokura, M.; Mori, J.; Tanimoto, T.; Abe, K.; Sakai, S.; Hayano, R.; Tokiwa, M.; Shimmura, H., 2016: Minimal Internal Radiation Exposure in Residents Living South of the Fukushima Daiichi Nuclear Power Plant Disaster. Following the Fukushima nuclear power plant disaster, assessment of internal radiation exposure was indispensable to predict radiation-related health threats to residents of neighboring areas. Although many evaluations of internal radiation in res...

Tysnes, O-Bjørn., 2006: Possibilities to help in amyotrophic lateral sclerosis. Tidsskrift for den Norske Laegeforening 126(19): 2505-2505

Whittenton, J.; Pitchumani, R.; Thevananther, S.; Mohanty, K., 2013: Evaluation of asymmetric immunoliposomal nanoparticles for cellular uptake. Effective and targeted in vivo delivery of polynucleotide therapeutics is the key for the treatment of many diseases. Asymmetric immunoliposomes can be used as vehicles to deliver polynucleotides effectively because the two leaflets of the bilaye...