Microbicides Dth Fbackground

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  • According to UNAIDS there are 40 million people world wide living with HIV/AIDS, and approx 5 million new infections occurred in 2003. Messages of prevention and safe sex are critical, but have not yet been universally successful in stemming the tide of this disease. Therefore the need for an effective HIV vaccine has been recognised in South Africa and, indeed, the rest of the world.
  • It is important to make clear that there is NO successful vaccine available yet – anywhere in the world. Even when there is a vaccine, it is critical that people still practice safe sex. As there can be no guarantee that a vaccine is 100% effective in preventing infection. Today we are talking about PREVENTATIVE vaccines, in other words the HIV vaccine would not be a cure for HIV, but rather offer protection to HIV NEGATIVE people.
  • Microbicides Dth Fbackground

    1. 1. <ul><li>Introduction to Desmond Tutu HIV Centre </li></ul><ul><li>Sipho January </li></ul>
    2. 2. Microbicides ( Masiphumelele and Nyanga ) Vaccine (Nyanga) Future Fighters ( Masiphumelele and Nyanga) Plus many more exciting projects Youth Centre Masiphumelele Women’s Health ( Masiphumelele and Nyanga) ART Clinic ( Masiphumelele and Nyanga) TB, Masiphumelele
    3. 3. Capacity Building in Masiphumelele <ul><li>The Desmond Tutu HIV Foundation is committed to capacity building within Masiphumelele where ever possible, and appropriate. </li></ul><ul><li>We currently employ from the community: </li></ul><ul><ul><li>11 field workers </li></ul></ul><ul><ul><li>3 community outreach workers </li></ul></ul><ul><ul><li>1 senior community outreach worker </li></ul></ul><ul><ul><li>4 counselors </li></ul></ul><ul><ul><li>3 data capturers / office administrators </li></ul></ul>
    4. 4. <ul><li>Microbicides: </li></ul><ul><li>The search for an HIV prevention tool for women </li></ul>
    5. 5. The face of HIV is increasingly… <ul><li>Female </li></ul><ul><li>Young </li></ul><ul><li>Married </li></ul><ul><li>A mother </li></ul>World Bank Photo
    6. 6. Microbicides are… <ul><li>Vaginal products to help women protect themselves against HIV </li></ul><ul><li>Not yet available – research ongoing </li></ul><ul><li>Could take many forms – all vaginal </li></ul>
    7. 8. Microbicides <ul><li>Based on ARV drugs </li></ul><ul><ul><ul><li>ARVs have been shown to reduce HIV transmission in certain settings: PMTCT and post-exposure prophylaxis </li></ul></ul></ul><ul><li>Longer-term protection / more convenient use </li></ul><ul><ul><ul><li>Once a day (gels) or once a month (rings) </li></ul></ul></ul><ul><li>Used vaginally - not orally </li></ul><ul><ul><ul><li>Avoid side-effects due to high levels of drug in the blood </li></ul></ul></ul>
    8. 9. Remember <ul><li>There is no successful HIV/AIDS Microbicide yet in the world. </li></ul><ul><li>Even with a Microbicide you still always have to practice safer sex. </li></ul><ul><li>A Microbicide is not a cure – it will aim to prevent infection in HIV-negative people. </li></ul>
    9. 10. Protocol 014B Gel Study
    10. 11. Protocol 014B <ul><li>A double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and acceptability of dapivirine gel 4789, a vaginal microbicide, conducted using Daily Monitored Adherence (DMA) in healthy HIV negative women. </li></ul>
    11. 12. Protocol 014B <ul><li>phase I/II </li></ul><ul><ul><ul><li>small numbers of women </li></ul></ul></ul><ul><li>placebo controlled </li></ul><ul><ul><ul><li>active gel versus no active gel </li></ul></ul></ul><ul><li>randomized </li></ul><ul><ul><ul><li>equal chance </li></ul></ul></ul><ul><li>double blind </li></ul><ul><ul><ul><li>hide who receives what </li></ul></ul></ul>
    12. 13. Study Design <ul><li>100 healthy women </li></ul><ul><ul><ul><li>20 at our site </li></ul></ul></ul><ul><li>10 weeks in duration </li></ul><ul><ul><ul><li>6 weeks gel use </li></ul></ul></ul><ul><li>10 women to participate in focus group discussion </li></ul><ul><li>10 male partners to participate in individual interviews </li></ul>
    13. 14. Eligibility Criteria <ul><li>Inclusion </li></ul><ul><ul><ul><li>Women >18 and <40 years of age </li></ul></ul></ul><ul><ul><ul><li>HIV negative </li></ul></ul></ul><ul><ul><ul><li>Healthy and sexually active </li></ul></ul></ul><ul><ul><ul><ul><ul><li>One penetrative vaginal coital act per month for the past 3 months </li></ul></ul></ul></ul></ul><ul><ul><ul><li>On contraception </li></ul></ul></ul><ul><ul><ul><li>Have a regular menstrual cycle </li></ul></ul></ul><ul><ul><ul><li>Can give written informed consent </li></ul></ul></ul><ul><ul><ul><li>Available for all study visits </li></ul></ul></ul><ul><ul><ul><li>Agree to daily gel application and DMA </li></ul></ul></ul>
    14. 15. Eligibility Criteria <ul><li>Exclusion Criteria </li></ul><ul><ul><ul><li>Currently pregnant </li></ul></ul></ul><ul><ul><ul><li>Currently breastfeeding </li></ul></ul></ul><ul><ul><ul><li>Symptomatic untreated vaginal infection or other gynae symptoms </li></ul></ul></ul><ul><ul><ul><li>History of severe allergy reaction – esp. to latex / silicone </li></ul></ul></ul><ul><ul><ul><li>Participation in any other research project within 60 days </li></ul></ul></ul>
    15. 16. Benefits for participants <ul><li>Full consultation with clinician </li></ul><ul><li>STI testing and treatment </li></ul><ul><li>Pap smear </li></ul><ul><li>Blood tests </li></ul><ul><li>Pregnancy testing </li></ul><ul><li>HIV testing </li></ul><ul><li>Extensive counseling </li></ul><ul><li>Free family planning (no cues) </li></ul>
    16. 17. Women Urgently Need Microbicides <ul><li>“ A microbicide could mean the difference between life and death for millions of women. Let us do everything in our power to accelerate its development.” </li></ul>Mrs. Graça Machel, March 2008

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