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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 + +

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


Mashi study

The Mashi Study: QUESTION #1

NAN

Formula Feed …OR… Breast Feed

+ +

1 mo AZT6 mos AZT


Mashi study

AZT

AZT

NVP

The Mashi Study: QUESTION #2

(MOTHER) (MOTHER)

1 Medication …OR… 2 Medications

(AZT) (AZT + NVP)


Mashi study

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


Mashi study

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


Mashi study

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


Mashi study

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


Mashi study

The Mashi Study: QUESTION #1

NAN

Formula Feed …OR… Breast Feed

+ +

1 mo AZT6 mos AZT


Mashi study

Mashi Study Results: Question #1(Infant HIV Positivity)

*Z-test based on difference in Kaplan Meier estimates with stratification by the 4 arms


Mashi study

Mashi Study Results: Question #1 (Infant Mortality)

Predominant causes of infant death: diarrheal disease and pneumonia



Mashi study

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)


Conclusion mashi question 1 thior et al jama 2006
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


Mashi study

AZT

AZT

NVP

The Mashi Study: QUESTION #2

(MOTHER) (MOTHER)

1 Medication …OR… 2 Medications

(AZT) (AZT + NVP)


Conclusion mashi question 2 shapiro et al aids 2006
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.


Aknowledgement
Aknowledgement:

  • BHP Study Team

  • Carolyn Wester