News

Microbicides 2010

May 22-25, 2010
Pittsburgh, PA

This year's Microbicides meeting was held in Pittsburgh, the city of bridges, and was aptly entitled “Microbicides: Building Bridges in HIV Prevention." More than 1,000 participants from across the globe came together to share information on HIV prevention. The meeting featured state-of-the-art plenary lectures on HIV prevention research, cross-disciplinary symposia on microbicides and other HIV prevention research, oral abstracts and poster sessions.

CONRAD Executive Director Henry Gabelnick Wins Lifetime Achievement Award

CONRAD Executive Director Henry Gabelnick, Ph.D., was awarded the lifetime achievement award at the conference. Before an audience of more than 1,000 HIV advocates and scientists, Dr. Gabelnick was recognized for his unparalleled commitment and dedication to the development of microbicides. The lifetime achievement award was his second - in 2005, Dr. Gabelnick was recognized by the International Conference on AIDS India for a lifetime devoted to reproductive health.

"In a field with so many dedicated, brilliant and persistent researchers, I am tremendously honored to be singled out by my peers," said Dr. Gabelnick. His acceptance speech described his early years working in the chemical industry, specifically in the field of plastics, and his journey to more fulfilling work in the field of contraception and microbicides. Dr. Gabelnick received his undergraduate and graduate degrees at MIT and his doctorate from Princeton. After beginning his career in the chemical industry, Dr. Gabelnick moved to the Biomedical Engineering Branch of the National Institutes of Health. He joined CONRAD at its inception in 1986, and focused primarily on developing new methods of contraception until it became clear that HIV prevention was crucial to overall reproductive health. For the past 20 years, CONRAD has contributed to the microbicide development field through the development of preclinical algorithms and primate models, standardization of colposcopy techniques, biomarker research and clinical trials.

CONRAD Presentations:

Assessing Markers of Inflammation after Vaginal Product Use: Nonoxynol-9, Cellulose Sulfate, and HEC Placebo Comparative Double-Blind Phase I Trial – Christine Mauck, M.D., M.P.H.

CONRAD is working to identify and validate new clinical biomarkers of microbicide safety. To assess markers of inflammation after use of nonoxynol-9, cellulose sulfate or placebo, 60 women were randomized to use one of the three products twice daily for 14 days. Preliminary analysis showed that nonoxynol-9 was associated with an inflammatory pattern of results, while cellulose sulfate was not. After vaginal use, cellulose sulfate retained its anti-HIV activity.

Colposcopy: Still Useful in Microbicide Safety Trials? – Christine Mauck, M.D., M.P.H.

A meta-analysis of nine trials was conducted to determine if colposcopy findings would have been missed with naked eye examination alone. Results showed that almost one-half of the findings observed in the trials would have been missed without colposcopy. However, analysis of a study comparing nonoxynol-9 (which is known to cause vaginal irritation when used often) and the HEC placebo showed no additional benefit from colposcopy, leading Dr. Mauck to recommend the continuation of naked eye examinations in all microbicide trials, omission of colposcopy in large trials, and replacement of colposcopy with a more objective validated biomarker of HIV risk.

Combining HIV Prevention and Contraception Technologies - Gustavo Doncel, M.D., Ph.D. 

Women in many areas around the world need protection from both HIV and unplanned pregnancy. To address this need, CONRAD and other organizations are developing intravaginal rings, barrier devices and gels that deliver anti-HIV and contraceptive drugs.

Evaluation of 6% Cellulose Sulfate and 0.5% PRO2000 Gel Microbicide Efficacy in a Single-Dose Intravaginal R5+X4 SHIV Infection Model in Rhesus Macaques Pre-treated with Depo-Provera – Mohammed Saifuddin, D.V.M., Ph.D.

Initial preclinical testing in a repeated low-dose primate model of the candidate microbicide cellulose sulfate showed it to be efficacious. The product, however, did not show efficacy in human trials. Subsequent testing in a single high-dose primate model showed cellulose sulfate and also PRO2000 (another microbicide candidate shown non-efficacious in human trials) to be efficacious. Reasons for the incompatibility between primate and human results may include: definition of protection, cutoff for predictive value, and/or inconsistent gel use by trial participants.

Gene Expression Profile of Vaginal Epithelial Cells Exposed to Proinflammatory Agents - Identification of Novel Biomarkers of Mucosal Safety - Irina Zalenskaya, Ph.D.

The gene expression profiles of human vaginal cells exposed to proinflammatory and noninflammatory compounds were analyzed. Profiling revealed a group of genes that is significantly upregulated in human vaginal cells in response to immunoinflammatory stimuli. These genes can serve as biomarkers of genital mucosal inflammation and immune activation.

Pilot Clinical Pharmacokinetic and Pharmacodynamic Study of UC781 Vaginal Gel – Jill Schwartz, M.D.

A pilot clinical study of the pharmacokinetics and pharmacodynamics of UC781 was conducted to: establish collection, transport and assay methodology; measure UC781 tissue and fluid concentrations; and measure HIV infection. The pilot data showed that freezing cervical and vaginal biopsies prior to ex vivo challenge was feasible and that viral replication results were similar with both frozen and medium transport methods. A recently validated assay for vaginal and cervical tissue concentrations of UC781 showed tissue concentrations higher than in vitro effective concentrations following a single dose. A single dose of UC781 reduced HIV transmission in vaginal biopsies. There was, however, a discrepancy in the ability of UC781 to block transmission in cervical biopsies; the reasons for this are being investigated.

CONRAD Poster Presentation:

Twenty-Eight Day Repeat Dose Toxicology Studies of UC781 Vaginal Gel in Sprague-Dawley Rats and New Zealand White Rabbits Following Rectal Administration – Timothy McCormick, Ph.D.

UC781 was applied to rats and rabbits rectally for 28 days and was well-tolerated. No local or systemic toxicity was observed in either species. These results provide the basis for moving into Phase I rectal application studies.

Other CONRAD Activities:

CONRAD co-sponsored the conference and also co-sponsored the Microbicides Media and Communications Initiative's (MMCI) Training and Resource Center. The Training and Resource Center directed attendees to expert sources on media related issues throughout the conference, as well as provided Skills on the Go training sessions on a variety of topics. 

For more information on the conference, go to: www.microbicides2010.org.   

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