DoD International Treatment Experience

1
DoD International Treatment Experience

• Debbi Birx
• Director, US Military HIV Research Program
• A partnership between the DoD and DAIDS

2
Lessons Learned from 18 years of HIV/AIDS in the
military

• From the beginning comprehensive care and
  treatment was linked to HIV/AIDS research
• The military community was provided with Care and
  treatment
• Uniformly available to all enlisted and officers
  of all racks and their families
• Research protocols were designed to specifically
  evaluate and potentially improve the standard of
  care
• Maintaining immune function
• New treatment options for failures
• Deployment issues
• Vaccine development requirements

3
Work and Think Spherically
Research
Health Care Prevention Treatment
Community Family
4
Field Site Philosophy

• Integration of permanent international state of
  the art research facilities with local MOPHs
  infrastructure to accomplish research mission
• Integrate HIV care/Tx/Prevention and Vaccine
  Development into one comprehensive initiative
• HIV care for vaccine participants is a
  requirement
• A credible prevention program must accompany any
  vaccine research study
• In resource poor settings, medical benefits
  including comprehensive HIV care and treatment
  must be available in the community
• Currently providing
• VCT (voluntary counseling and testing)
• Accurate diagnosis and treatment of opportunistic
  infections in HIV ()
• Maternal to care prevention using Neviripine
• Comprehensive Treatment short of Antiretrovirals
• PEPFAR dollars critical to providing funding for
  Antiretrovirals

5
Continuum of Public Health
Vaccine research, design, production and testing
Basic Research
Rapid test algorithms
Cohort Recruitment
Laboratory QA/QC
Incidence/prevalence
Behavioral studies
ARV and Productivity Study - Kenya
Prevention campaigns PMTCT/VCT
OI treatment/prophylaxis
MARVIN ARV Study - Tanzania
Disease course
PAF PMTCT Program (17,000 enrolled)
Retention and follow up of patients
6
Laboratory and IT developmentProviding the
platform for PEPFAR

• Tech transfer from established lab
• Standard local cell processing under 4 hours
• Uniform SOPs and equipment if plausible
• Establish normal values for population - safety
  etc
• Choice of assay test kits - US FDA versus country
  endorsement
• Are the logistics plausible
• Safety labs important to the local health care
  delivery
• HIV diagnostic and monitoring labs impt to VCT
  and treatment initiatives
• Endemic diseases diagnosis important to both
  local health care and vaccine performance
• IT support - LIMS, impt for patient and research
  volunteer record tracking

7
(No Transcript)
8
PEPFAR /DoD/ USMHRP

• Leveraging HIV Research Infrastructure and
  Capacity for Development of Comprehensive Care
  for HIV/AIDS
• All the elements necessary for a community based
  HIV vaccine trial are needed for comprehensive
  HIV care and treatment including
• Pharmacy
• Health Facilities and Human Resources
• Clinical labs
• Community Relationships

9
U.S. Military HIV Research Program Vaccine
Cohort/Care and Treatment Sites, East Africa
UGANDA
Kericho/Bomet
KENYA
Rakai
TANZANIA
Mbeya
10
PEPFAR Goals 2-7-10

• By the end of five years
• Treating 2 million individuals with ART
• Prevented 7 million new infections
• Providing care and support to another 10 million
  HIV individuals
• Kericho ART treatment
• Week one 1
• Week two 36
• Week three 77
• Week four 120
• Week five 156
• 2x in care

11
WRP -Kericho Clinical Research Center
Infrastructure and Training
12
Partnership
13
Innovation
14
Maternal - Child Health Block
15
KDH Pharmacy
16
Expanded HIV/AIDS Outpatient Clinic
17
Expanded Outpatient Pharmacy
18
First Delivery of ARVs to the Kericho Region
19
LIVE WITH HOPE CENTERVCT, clinic and support
20
Companion Research Initiatives Supported by the
NIH/DAIDS in the DoD PEPFAR Area

• Kericho SUSTAINABILITY
• Funding full research protocol (including ARTs)
  to evaluate effect of ART and expanded care on
  productivity
• Critical to demonstrate to MOH and corporations
  clear improvement in worker output
• Mapping potential shift of inpatient to
  outpatient care with decreased health care cost
• Mbeya FDC (knock-off vs branded)
• Bioavailability
• Compliance
• Side effects
• Flexibility in dosing and prescribing
• Resistance

21
Summary

• USMHRP and its local partners have a long history
  of collaboration and through this have developed
• Extensive local research and laboratory
  infrastructure and capacity
• Technical in country expertise critical to
  prevention and treatment interventions
• Excellent administrative infrastructure
• Capacity to implement prevention and care
  programs
• Partnerships with local health care services and
  NGO to broaden the scope of prevention and
  treatment activities
• A vehicle by which to develop, evaluate and
  support implementation of appropriate
  interventions, bridging the gap between research
  and treatment programs
• The proposed care and treatment program will
  expand on research/prevention/care activities
  already supported by the U.S. Government to now
  address new directives under PEPFAR to implement
  a more complete treatment based program that is
  fully integrated and leveraged against
  established research infrastructure.

22

Botswana-HSPH Partnership Vaccine Think Tank

• GLOBAL IMPACT OF
• INFECTIOUS DISEASES AND VACCINES
• Barry R. Bloom
• Harvard School of Public Health
• Joshua Salomon
• Daniel Hogan
• Population and International Health
• Harvard Center for Population and Development
  Studies
• April 30, 2004

23
SUCCESS STORY - BRAZIL

• Pop 170 million
• GDP/capita 6,625
• Cumulative AIDS Cases 210,447
• HIV individuals 578,000
• 100,000 on 8 local ARVs, free through 656 care
  services
• Mortality gt50? Predicted prevalence 50?
• OIs Decline 70?
• Hospitalizations 80?
• Drug Costs 50?
• Savings 700 million, 1997-2000
• National AIDS Drug Policy, MOH, Brazil 2001

24
ARV scenarios
Baseline No ARVs 2 - 3 million new infections
per year 1.5 - 2.5 million deaths per year
difference from baseline

• 3 by 5 scenarios
• Success
• Survivorship 6 years
• Infectiousness -99
• Risk behavior -50
• Failure
• Survivorship 2 years
• Infectiousness -50
• Risk behavior -50
• Worst Case
• Survivorship 4 years
• Infectiousness -80
• Risk behavior unchanged

25
Thank you

• The team in Rockville, Mbeya Tanzania, Kericho
  Kenya, Kampala and Rakai Uganda, Limbe and
  Yaloude Cameroom, and Thailand
• Their faith, dedication, and unwillingness to
  accept less or the status quo

26
Integrating prevention and treatment
Difference from baseline under various scenarios
ARV success prevention
27
Integrating prevention and treatment
Difference from baseline under various scenarios
minus good adherence
ARV success prevention
28
Integrating prevention and treatment
Difference from baseline under various scenarios
minus reductions in patient risk behavior
minus good adherence
ARV success prevention
29
Integrating prevention and treatment
Difference from baseline under various scenarios
minus prevention in community
minus reductions in patient risk behavior
minus good adherence
ARV success prevention
30
Integrating prevention and treatment
Difference from baseline under various scenarios
plus disinhibition
minus prevention in community
minus reductions in patient risk behavior
minus good adherence
ARV success prevention
31
Current USMHRP Track 2.0 Submissions

• Kenya 1,920,000 (Total award with 1.5
  3,300,000)
• Tanzania 3,834,700

Kenya
Tanzania
32
Vaccine Cohort Development Tanzania

• Established 1999
• Mbeya, Tanzania
• Cost 3.2M/yr
• Personnel 108
• HIV incidence 1.5 -17
• HIV prevalence 17-68
• VRC Phase I trial FY04
• VRC Phase II trial FY05
• MVA (A,D,C) Phase I trial in FY05
• Lfn p24/env C Phase I trial FY05
• PEPFAR funding 4 M with an addition 1.2 M for ARVs

33
Vaccine Cohort Development Kenya

• Established in 1999
• Kericho Kenya
• Cost 5.5 M
• Personnel 78
• Enrolled 4353 volunteers
• HIV prevalence 14
• Malaria 4
• STDs 13
• VRC Phase I trial in FY04
• VRC Phase II trial in FY05
• MVA (A,D,C) Phase I trial FY05
• Providing care and treatment of 4500 individuals
  short of ARVs
• Providing Maternal to Child transmission
  prevention gt8600
• PEPFAR 3.2 M (1.1M addition ARV) FY04

34
Vaccine Cohort Development Uganda

• Established in 1998
• Invested 18M
• Personnel 58
• Previously supported Rakai cohort, Uganda 17,000
  volunteers enrolled
• HIV incidence 1.3, prevalence 14
• Evaluating new potential cohorts
• Greater Rakai
• Kampala area
• Western Uganda
• Occupational cohort
• Initiating Phase I trial of VRC candidate in May
  2004
• Phase II VRC trial FY2005
• MVA D in GMP production April 2004

35
Vaccine Cohort Development Cameroon

• Populations
• 1000 in the Cameroon Military (pop.10,000)
• 1000 at HEVECAM, an agricultural plantation (pop.
  27000)
• 1000 at Cameroon Development Corporation, an
  agricultural plantation (pop 65,000)
• Study Duration
• Accrual 12 mo and 36 mo follow-up
• Primary Objectives
• Determine prevalence and incidence of HIV-1
  infection in a cohort of military, plantation and
  rural populations in southern Cameroon
• Characterize behavioral risk factors associated
  with HIV-1 infection
• Determine willingness of participants to enroll
  in future HIV-1 vaccine trials

RV157Prevalence, incidence, and diversity of
HIV-1 infection among military, plantation, and
rural populations in Cameroon