The Department of Health and Human Services/Centers for Disease Control and Prevention (CDC), Procurement and Grants Office (PGO), intends to award on a SOLE SOURCE BASIS RFP# 200-2004-08375 entitled, “Procurement of Microbicide Product Cellulose Acetate Phathalate (CAP). The RFP number for this acquisition is RFP 200-2004-08375. The Contract will be awarded to NYBC (New York, NY), The solicitation will be released on or around July 26, 2004. The deadline for receipt of proposals is August 9, 2004. The Contact for this acquisition is Marcus A. Powell, Contract Specialist, Telephone: (770) 488-2608, E-mail
[email protected], and the fax number is (770) 488-2670. Statement of Work/background & Needs- Heterosexual transmission causes more than 85 percent of the HIV infections worldwide and a rapidly increasing proportion of HIV/AIDS cases reported in the United States. In 2000 worldwide, 4.7 million adults ages 15-49 acquired HIV infection, 2.2 million (47 percent) of them women (UNAIDS 2000). Despite gains in male condom use over the past 20 years, many women find that their partners are unwilling to use condoms consistently. In the U.S., the consequences of these behaviors and attitudes are reflected in continuing HIV transmission, with increasing concentration among women. In 2002, women accounted for 26 percent of reported adult AIDS cases and in the 30 areas that also report HIV infection without AIDS, 28 percent of reported HIV infections occurred in women, 39 percent among those ages 13-24 (CDC 2003). These trends reinforce the importance of identifying and testing new prevention methods for heterosexual women and men. In the past few years, much effort has gone into developing methods which can be used in combination with other prevention interventions for protection against HIV infection. Several promising microbicides, chemical compounds which can be applied topically and which inactivate or kill HIV, have been identified in laboratory and animal studies (Van Damme 2000, Rosenstein 1998, Coggins 2000, Piret 2000, Manson 2000). Several studies have indicated that women (and their male partners) would use a microbicide if it were shown to protect against HIV infection (Darroch 1999, Blanchard 1998, Bentley 1998, Bentley 2000, Hammett 2000). Cellulose Acetate Phathalate (CAP), a compound which has long been used as a drug excipient, has been formulated into a gel that may be applied topically to the vagina for prevention of sexual transmission of HIV-1. Preclinical studies have demonstrated promising anti-HIV activity and low toxicity of this formulation. The New York Blood Center, Inc. (NYBC) is the sole holder of the rights to development of UC-781 as a topically applied microbicide. CAP was selected for the clinical trials described in this document through an open, competitive process. This process was initiated through an announcement soliciting collaboration from entities holding interest in potential anti-HIV topical Microbicides which appeared in the Federal Register in June, 2001. Proposals were received for a total of five different agents which were tested by CDC laboratory scientists for in vitro toxicity and anti-HIV activity. CAP was selected for clinical trial based upon its favorable performance in these in vitro studies.