Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach

Alfred Shihata, MD

Current Problems

• No Cure• No Vaccine• Condom is not an option for

many women• So far Microbicides, have

failed

The Condom

Microbicides• Kill the HIV virus in the in-vitro• So far microbicides are not proven to

be effective in the vagina• N-9 and Cellulose sulfate increased

the HIV transmission when compared to placebo

• Pro-2000,Buffergel,and Carragaurd were safe but not effective

Valuable Lessonsfrom the Microbicides clinical trials

We must not forget…

• Anatomy

• Physiology

• Immunology

of the cervix and the vagina

Anatomy and Physiology

of the Vagina

Immunology

Unlike all other viruses, the HIV virus attacks and destroys the immune cells. Therefore the more immune cells at the cervix, the higher the risk for HIV transmission.

Microbicides irritate the cervix and provoke an immune response

Objectives for STI/ HIV prevention by this new dual strategy

• It must be woman-controlled, and coitally independent.

• To kill the HIV virus before it enters the cervical or vaginal cells.

• To shield the cervix and vagina from HIV invasion and microbicide irritation.

• Eliminate or minimize contact of the HIV virus to the genital mucous membrane .

• To prevent pregnancy.

Microbicides still hold the best promise for HIV prevention

The FemCap is designed to enhance the safety and efficacy of microbicides

Criteria for the ideal Microbicide

Should be gentle enough not to irritate the cervix or provoke an immune response

It should be strong enough to kill the STIs and HIV microorganisms

It should NOT disrupt the vaginal ecosystem.

Stronger is not better

The FemCap prevents sperm and STI/HIV from entering the cervix

The FemCap’s MicrobicideDelivery System Mimics Test Tube Condition

This unique delivery system is facing the vaginal opening to protect the cervix.

Uterus (Womb)

The FemCap

covering the cervix

Vagina

The FemCap effectively protects the cervix and prevents sperm, bacteria and viruses from entering the cervix

New Delivery System

FemCap

FemCap with Microbicide& Gentian Violet

Healthy Cervix and Vagina

FemCap + Microbicide / Gentian Violet dye left in situ for 6 hours

Microbicide / Gentian Violet dye in the FemCap Delivery System

Cervix and Vagina after removal of FemCap

Result, No stain was

visible over the cervix

Facts1. HIV virus is very fragile in-vitro.

2. The cervix is the main portal of entry to the HIV virus.

3. Thus far all Microbicides have failed

4. Microbicides applied by applicator or diaphragm may elicit an immune response and disrupt the vaginal ecology.

5. Many people do not accept the condom due to interruption of spontaneity and reduced sexual sensations.

FemCap• The FemCap does not interrupt spontaneity or

reduce sexual pleasure to both partners.

• It is a fit and forget for 48 hours.

• It is woman-controlled and coitally independent.

• It is re-usable for one-two years, and does not pose any environmental hazards

• It is FDA approved, inexpensive and made of non-allergenic materials

February 7, 2007 (Revised)US Principal Investigator: Ariane van der Straten, PhD, MPHWomen’s Global Health ImperativeDepartment of Obstetrics, Gynecology and Reproductive SciencesUniversity of California, San Francisco

Zimbabwe Principal Investigator: Michael Chirenje, MD, MRCOG, FRCOGUniversity of Zimbabwe: University of California, San FranciscoCollaborative Programme in Women’s Health

Feasibility and acceptability of cervical barriers (CB) among vulnerable youth:in Africa, A pilot study in Zimbabwe

CB Practice Results (n=45) (n=16)

Inserted properly at first attempt (%) 81.3

Removed properly (%) 93.8

Liked the device she tried (%) 87.5

FemCap

In SummaryThis dual strategy of FemCap/Microibicide can potentially achieve the three critical goals:

1. Prevent HIV transmission2. STI infections3. Prevent Pregnancy

HIV

PREGNANCY STI