Microbicides background

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Microbicides background

  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)
  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. 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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