1 / 17

Mashi Study

Mashi Study. Dr T Gaolathe Botswana Harvard School of Public Health AIDS Initiative Partnership. Botswana National Program for PMTCT (Launched June 1999; country-wide Nov 2001). The Mashi Study: QUESTION #1. NAN. Formula Feed …OR… Breast Feed + +

vivian-charles
Download Presentation

Mashi Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Mashi Study Dr T Gaolathe Botswana Harvard School of Public Health AIDS Initiative Partnership

  2. Botswana National Program for PMTCT(Launched June 1999; country-wide Nov 2001)

  3. The Mashi Study: QUESTION #1 NAN Formula Feed …OR… Breast Feed + + 1 mo AZT6 mos AZT

  4. AZT AZT NVP The Mashi Study: QUESTION #2 (MOTHER) (MOTHER) 1 Medication …OR… 2 Medications (AZT) (AZT + NVP)

  5. Mashi: Study Design • Randomized partially blinded placebo controlled clinical trial with a 2 x 2 factorial design • 1200 HIV-1 infected pregnant women enrolled at 34 weeks gestation • Mothers and infants are followed until 2 years after delivery • 1 urban and 3 rural locations in Botswana • Gaborone, Molepolole, Mochudi, and Lobatse

  6. The Mashi Study: Original Design NAN NAN MOTHER AZT AZT MOTHER BABY MOTHER BABY NVP NVP NVP SD NVP SD NVP SD NVP Placebo SD NVP Placebo Formula Feeding + 1 mo infant AZT Breast Feeding + 6 mos infant AZT Formula Feeding + 1 mo infant AZT Breast Feeding + 6 mos infant AZT

  7. The Mashi Study: Amended Design NAN NAN MOTHER AZT AZT MOTHER BABY MOTHER BABY NVP NVP NVP SD NVP SD NVP SD NVP Placebo SD NVP Formula Feeding + 1 mo infant AZT Breast Feeding + 6 mos infant AZT Formula Feeding + 1 mo infant AZT Breast Feeding + 6 mos infant AZT

  8. Botswana National Program for PMTCT(amended) Additional Provisions for: Mother NVP: Single-dose (200mg) at onset of labour upon admission to L&D Infant NVP: Single-dose (3mg / kg) stat after delivery

  9. The Mashi Study: QUESTION #1 NAN Formula Feed …OR… Breast Feed + + 1 mo AZT6 mos AZT

  10. Mashi Study Results: Question #1(Infant HIV Positivity) *Z-test based on difference in Kaplan Meier estimates with stratification by the 4 arms

  11. Mashi Study Results: Question #1 (Infant Mortality) Predominant causes of infant death: diarrheal disease and pneumonia

  12. Mashi: Feeding Strategy Results

  13. Mashi Study Results: Question #1 (Infant HIV Infection or Death) • By 18 months: • HIV-free survival 85.8% in FF and 84.4% in BF+ZDV arms • 79 endpoints in FF (33 HIV positive,46 deaths) • 88 endpoints in BF (54 HIV positive, 34 deaths)

  14. Conclusion: Mashi Question #1(Thior et al, JAMA 2006) • Formula feeding was associated with lower 7-month HIV transmission rates but higher mortality rates than [breastfeeding + ZDV] for 6 months • 18-month HIV-free survival rates were comparable and high in the FF and BF+ZDV arms (85.8% and 84.4%, respectively) • Both FF and BF+extended ZDV are reasonable strategies for PMTCT • Choice of strategy should depend upon local circumstances

  15. AZT AZT NVP The Mashi Study: QUESTION #2 (MOTHER) (MOTHER) 1 Medication …OR… 2 Medications (AZT) (AZT + NVP)

  16. Conclusion: Mashi Question #2(Shapiro et al, AIDS 2006) • No advantage to maternal SD NVP when: • Pregnant woman receives > 4 weeks of AZT received antenatally, and • Infant receives sd-NPV immediately after birth plus 4 weeks of AZT • An effective short-course PMTCT strategy that spares maternal NVP exposure is possible for regions where prophylactic maternal and infant ZDV can be used.

  17. Aknowledgement: • BHP Study Team • Carolyn Wester

More Related