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Direct measurement of in-vivo vaginal microbicide levels of PRO 2000 achieved in a human safety study

Lacey, C.J.N., Wright, A., Weber, J.N. and Profy, A.T. (2006) Direct measurement of in-vivo vaginal microbicide levels of PRO 2000 achieved in a human safety study. Aids, 20 ( 7). pp. 1027-1030. ISSN 0269-9370

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Abstract

OBJECTIVES:

To directly measure the cervico-vaginal lavage (CVL) and plasma PRO 2000 concentrations achieved by vaginal dosing.

DESIGN:

A sub-study of a prospective randomized, double-blind phase 1 trial of a candidate vaginal microbicide, PRO 2000 gel.

METHODS:

Thirty-six sexually abstinent women self-administered 4% PRO 2000 gel, 0.5% PRO 2000 gel or placebo gel twice on day 0 and then once daily for a further 12 days.

RESULTS:

There was no evidence of systemic absorption of PRO 2000. PRO 2000 concentrations in CVL exceeded 25 µg/ml in all women in both the 4 and 0.5% groups at 2 h post-first dose, and in 10 of 12 of the women in the 4% gel group compared with five of 12 of women in the 0.5% group at 12 h post-seventh dose. Single use of both 4 and 0.5% PRO 2000 gels was therefore associated with levels of PRO 2000 in CVL that would be capable of preventing HIV infection in vitro, although the 4% gel gave a greater margin of excess. Levels substantially in excess of the target concentration were present 12 h after repeated dosing in twice as many 4% gel recipients compared with 0.5% gel recipients.

CONCLUSIONS:

Both PRO 2000 gel strengths provided satisfactory in-vivo HIV inhibitory concentrations. However, our observations show that higher concentrations of PRO 2000 are likely to provide a greater margin of potential efficacy in the context of sexual intercourse provided safety issues are equivalent for differing concentrations of the agent.

Item Type: Article
Institution: The University of York
Academic Units: The University of York > Hull York Medical School (York)
Depositing User: York RAE Import
Date Deposited: 13 Aug 2009 14:55
Last Modified: 13 Aug 2009 14:55
Published Version: http://dx.doi.org/10.1097/01.aids.0000222075.83490...
Status: Published
Publisher: Lippincott, Williams & Wilkins
Identification Number: 10.1097/01.aids.0000222075.83490.ca
URI: http://eprints.whiterose.ac.uk/id/eprint/5485

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