AIDSWEEKLY Plus; Monday, November 14, 2005
Staff Medical Writers

The trial is being sponsored by the Medical Research Council of the United Kingdom (MRC) and conducted by the U.K. government-funded Microbicides Development Programme (MDP).

The trial has opened for enrollment at clinics in Johannesburg, South Africa and the Masaka district of Uganda, and is expected to expand to additional sites in South Africa, Tanzania and Zambia. Approximately 10,000 women will be enrolled in the trial, which is expected to last approximately 3 to 4 years and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring committee.

"With the initiation of this study, two large safety and effectiveness trials of PRO 2000 with combined recruitment targets of approximately 13,200 participants are underway," said Glenn L. Cooper, MD, chairman, president and chief executive officer of Indevus. "In February of this year, we announced the initiation of an NIH-sponsored trial being conducted at sites in the U.S. and a number of African countries. Together the two trials represent approximately $100 million in funding.

"We believe, upon successful completion of the trials, we would be in position to file marketing applications with regulatory authorities, including a New Drug Application with the U.S. Food and Drug Administration. In addition to the work being done on the two trials, we have begun discussions with potential public and private sector partners for the commercialization and distribution of PRO 2000," continued Cooper.

"Nearly half of all people living with HIV worldwide are women, and the majority of new adult HIV infections are acquired from heterosexual intercourse," said Cooper. "The highest infections rates are found in sub-Saharan Africa, which is the primary area where both PRO 2000 trials are being conducted. Globally, there is a significant need among sexually active women for a female-controlled option for HIV / STD prevention.

"We are pleased that the MRC has selected PRO 2000 as the only active agent in this significant international microbicide trial. The MRC trial is the result of a long-standing and productive public-private partnership," concluded Cooper.

Each woman enrolled in this double-blind, placebo-controlled trial will be assigned at random to receive one of two PRO 2000 strengths (0.5% or 2%) or a placebo. The women will be asked to apply the study product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counseling. Researchers will evaluate the effectiveness of PRO 2000 relative to placebo in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia.

The development program for PRO 2000 includes a number of preclinical and early clinical studies conducted by government agencies and research organizations in the U.S., Europe, Africa and India. An NIH-supported study demonstrated that PRO 2000 can afford protection from the sexual transmission of HIV in an animal model.

Results from a phase I/II trial conducted by the NIH, in which no serious side effects were reported and investigators concluded that PRO 2000 was safe and well tolerated, were presented at the International Congress of Sexually Transmitted Infections in June 2001. Other phase I trials showed a promising safety and acceptability profile for the drug in healthy, sexually abstinent women.

In addition, phase I trials designed to evaluate the safety of male exposure to PRO 2000 were conducted. There were no serious side effects reported and investigators concluded that PRO 2000 was safe and well tolerated.

In June 2003, a phase II trial funded by the European Commission was initiated in Uganda to assess the safety of PRO 2000 in approximately 200 sexually active women. Findings from a study conducted at the Mount Sinai School of Medicine were presented earlier this year at the 12th Conference on Retroviruses and Opportunistic Infections. The findings demonstrated that PRO 2000 retained activity against HIV and HSV following intravaginal administration to HIV-infected women.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Marla Keller, B Zerhouni-Layachi, N Cheshenko, et al., "The Candidate Topical Microbicide PRO 2000/5 Inhibits HIV and HSV Infection following Vaginal Application: Results of a Double-blind Placebo-controlled Trial", Conf Retroviruses Opportunistic Infect 2005 Feb 22-25;12: (Abstract 535).

AEGiS Related articles Search

051114
AW051106

Copyright © 2005 - Charles Henderson, Publisher. All rights Reserved. Permission to reproduce granted to AEGIS by Charles W. Henderson. Authorization to reproduce for personal use granted granted by C. W. Henderson, Publisher, provided that the fee of US$4.50 per copy, per page is paid directly to the Copyright Clearance Center, 27 Congress Street, Salem, Massachusetts 01970, USA. Published by Charles Henderson, Publisher. Editorial & Publishing Office: P.O. Box 5528, Atlanta, GA 30307-0528 / Telephone: (800) 633-4931; Subscription Office: P.O. Box 830409, Birmingham, AL 35283-0409 / FAX: (205) 995-1588 http://www.newsrx.net

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, Bridgestone/Firestone Charitable Trust, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright © 1980,2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.