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MDP 301

MDP 301. AN INTERNATIONAL MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF 0.5% AND 2% PRO 2000 GELS FOR THE PREVENTION OF VAGINALLY ACQUIRED HIV INFECTION FUNDED BY UK MRC AND DFID TRIAL RESULTS DECEMBER 2009. OBJECTIVE.

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MDP 301

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  1. MDP 301 AN INTERNATIONAL MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF 0.5% AND 2% PRO 2000 GELS FOR THE PREVENTION OF VAGINALLY ACQUIRED HIV INFECTION FUNDED BY UK MRC AND DFID TRIAL RESULTS DECEMBER 2009

  2. OBJECTIVE The primary objective of the trial is to determine the efficacy and safety of 0.5% & 2% PRO 2000 gel compared to placebo gel in preventing vaginally acquired HIV infection

  3. MDP 301 STUDY SITES AFRICA • Uganda: • Masaka Tanzania: • Mwanza Zambia: • Mazabuka South Africa: • Mtubatuba • Durban • Johannesburg Uganda Tanzania Zambia South Africa

  4. STUDY DESIGN Phase III Clinical Trial HIV-negative, sexually active, non-pregnant women, 16y or older (18y in SA and Zambia) PRO 2000 0.5% + Condoms PRO 2000 2% + Condoms Placebo + Condoms All participants received HIV counseling and testing, free condoms, and diagnosis and treatment of curable STIs

  5. OVERVIEW OF PARTICIPANTS

  6. MDP 301 RETENTION

  7. MDP 301 ADHERENCE (excluding women on 2%) 1 Gel used at last sex act with or without a condom. 2 Gel and condom used at last sex act 3 Gel used when last sex was without condom: ( n gel use / n unprotected sex acts) (%)

  8. PRIMARY EFFICACY ANALYSIS - HIV-1INFECTION BY ARM - COMPARISON There were two modifications to a classic intention to treat analysis for the main analysis • Women were censored when they stopped gel for pregnancy • HIV seroconversions beyond the visit window for week 52 were excluded

  9. HIV-1 INFECTION BY ARM FEBRUARY 2008 NB: 2% discontinued on 14th February 2008.

  10. Conclusion • There was no significant difference in the rate of HIV infection between 0.5% PRO 2000 and placebo. • There was no significant difference in the rate of HIV infection between 2% PRO 2000 and placebo. • There was no significant difference in the safety markers between 0.5% PRO 2000 and placebo. • There was no significant difference in the safety markers between 2% PRO 2000 and placebo.

  11. KEY MESSAGES • Women and their partners liked the gel and used it • The study teams made supreme efforts to remind women about their appointments and the women came • Therefore the participants and staff gave PRO 2000 the best chance, and it is disappointing that the gel did not add benefit to the HIV prevention package • The study benefited women: regular exams, STI testing and treatment, risk reduction and supportive counseling • Male and Female condoms remain the most suitable option for HIV prevention

  12. What’s Next • MDP 301 and previous microbicide trials strongly support the concept, as women do use the products • We hope the ARV microbicides, which are much more potent in the laboratory, will prove to be effective in the two clinical trials that are ongoing • The results from PrEP research with oral ARV are also eagerly awaited eg. Tenofovir & Truvada • Infrastructure is there and ready for the next trials • The microbicide field should not lose hope of finding a women initiated product for HIV prevention

  13. ACKNOWLEDGEMENTS • Participants and their partners • Trial communities • Research teams • IRBs and Regulatory agencies at each participating site • Trial Steering Committee and Independent Data Monitoring Committee • Donors: Department for International Development (DFID) and UK Medical Research Council • Commercial partner • Indevus/Endo

  14. MDP Partnership

  15. Dissemination in clinical trial communities • National and provincial stakeholders • Clinical trial staff • Local stakeholders • Participants • Unblinding • Community members • Future dissemination plans

  16. Reactions • HIV education • Communication skills • Increase in condom use • Empowerment • Action • Community recognition • High quality service

  17. Participant Quote • “Even if the gel may prove not effective, we played a role in the fight against HIV. We learnt about caring for ourselves – like screening for cervical cancer and using condoms. This research taught us a lot: we even learnt to encourage others to test for HIV and we gained confidence of helping those already infected”.

  18. SiyabongaKakhulu

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