Transcript Accomplishments:

Accomplishments Year 1
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Encouraged HIV testing counseling with referrals
to Phidisa 1
Education of Nursing Staff on Pediatric Wards
Lectures to Medical Officers and Interns in
Pediatric Unit
Training in US
US Collaborator: 2 week visit
Treatment SOP for children (needs refinement)
Accomplishments:
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HIV testing of 27 children: 24 were positive
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10 did not return for test results and were infected
9/14 qualified for treatment
Age: 1-10
CD%: 0.76%-32.9%
HIV RNA : imdetectable-1,382,000/copies/ML
Weight: 3 severely malnourished (< marasmic
line); 11 >3%; 1 only at 50%
Ht : 6; <3%; 8: >3%: 10 yo at 25%
Accomplishments
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ARVs for 9 thus far:
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2: d4T/3TC/Kaletra (1 severe encephalopathy:
cannot walk)
7: d4T/3Tc Efavirenz
Outcome 1 month: minimum weight gain 1
Kg
Goals
Establish a Multidisciplinary Family Clinic:
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to provide primary and tertiary care: to start one day per
week and then as needed
ensure access to research and adherence with
research and treatment protocol visits.
Recruit and Train multidisciplinary team:
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Pediatrics, Ob/Gyn, Internal Medicine, Nutrition, Mental
Health, Community Health ( Vaccinations),
Occupational Health, Neurodevelopmental, Nursing and
Social work Case Management to care for women and
children affected by HIV.
Goals
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Assure that all staff are trained to
discuss educate patients on benefits of
research through Phidisa.
Incorporate research in all aspects of
care and integrate clinical and research
staff so that all patients are offered
access to research protocols
Goals
Enroll into Phidisa-1: 500 HIV infected infants,
children and their mothers and provide ARVs
where eligible through PEPFAR.
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Routine Maternal prenatal visits q month then weekly
as per standard OB protocol
Pediatric routine clinical visits q 1-3 months. For
infected neonates at 2 weeks, 4-6 weeks, 4, 6 month 9,
months, 12, 15 months and then routinely
Integrate maternal and infant/child visits with
Phidisa 1 research visits at 6 month intervals as per
Phidisa 1 protocol
Goals
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Reduce Perinatal Transmission to 0-2%:
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Establish 2-3 Perinatal Centers
 starting with open sites-1 and 2 MH to include Ob,
Pediatric and Internal Medicine providers to manage
and deliver perinatal care to HIV+ pregnant women
and their neonates.
 Specialized Trained Staff in labor and delivery
Rapid test available in the Delivery Room
 Establish 24 hour call system for Ob/Peds
 Collect Research data on pregnancy, co-infections (
TORCH, Grp B Strep) and labor and delivery
complications, and infant outcomes (Apgars, wt/ht etc)
Goal: Reduce Perinatal Transmission
to 0-2%:
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Provide Routine Prenatal Care to HIV+ pregnant women:
Start with one half day a week clinic
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Utilize a standardized perinatal care and treatment protocol
across sites
 in terms of routine visits, and obstetrical practices in
labor and delivery. ( ie no forceps, , what to do with
PROM, high viral load, presentation without prenatal
care etc.) at designated delivery sites
 Coordinate care OB care with HIV care
 Early involvement with Pediatrics to review care and
discuss breastfeeding risks of transmission
 Review risk/benefits of traditional healers
Goal: Reduce Perinatal Transmission
to 0-2%:
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Enroll in Phidisa-1 HIV+ pregnant women and through
PEPFAR provide treat/prophylaxis with HAART for maternal
health and prevention of perinatal transmission for 800 HIV+
pregnant women and their neonates.
 Treatment for naïve women: ZDV/3TC, ZDV/ddI + NVP
(if CD4 count <250) ( to be discussed)
 Treatment for when past ARV HX depending on viral
load
 Achieve RNA <50 copies
 Monitor for viral rebound
 Monitor closely for toxicity (especially liver enzymes):
Final protocol to be determined
 Alter regimen with no response or inadequate
response within 2 weeks, and one month
Drug Regimen for Mother
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Treatment for naïve women: ZDV/3TC, d4T/3TC,ZDV/ddI +
NVP (depending on CD4)//Nelfinavir/Kaletra (poor PK?) during
pregnancy/ IV ZDV at delivery or ? Oral ZDV/3TC (Pending final
approval by OBs)
Treatment with past ARV HX or Phidisa 2 pregnancy or high
CD4 depending on viral load; d4t/3TC, AZT/ddI; EFV 
Nelfinavir ( good data) ; Kaletra (Need better PK Data??)
remains as is.
Monitor RNA closely;
 Achieve RNA <50 copies
 Alter regimen with no response or inadequate response within 2 weeks, and one
month
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If on Phidisa 11 Change Efavirenz to NVP if RNA < 50 copies/mL and CD4 < 250
 Change Efavirenz to PI with detectable RNA
Drug Regimen for Neonate
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If Mom has RNA <1,000 treat with oral ZDV for 6 weeks
If maternal viral load > 1,000 add 3TC
If no maternal ARVs no prenatal care: use triple therapy
(Final in depth protocol for review)
Early diagnosis with DNA PCR (birth, 2 weeks, 4-6 weeks, 4
months) with early treatment
In utero DNA PCR+ infants begin treatment ASAP: HAART
(zdv/ ddI or 3TC/NVP final regimen pending)
Primary care coordinated with HIV care: growth and
development/nutrition; vaccines (including varicella); drug
toxicity monitoring.
PCP prophylaxis for HIV unknown status and HIV+ neonates
Treatment
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Group 1: Infants < 6weeks of age – HIV exposed
infection status not yet known
Term Infants should receive NVP 6 mg (~2mg/kg) once
(assuming that mother also received a dose) and ZDV
4mg/kg q 12hr + 3TC 2mg/kg q 12hr for 6 weeks.
(Alternative to 3TC is DDI) For cases of no maternal
treatment and/or high viral load consider continuing NVP for
6 weeks (check on dosing of NVP in neonatal period).
Maternal Prenatal Care > 2 weeks formula fed (and HIV RNA
< 1000)
Term Infant should receive ZDV 4mg/kg q 12hr for 6 weeks
Treatment
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Group 2: Infants > 6weeks of age – HIV exposed
infection status negative or unknown and breast feeding
A. 3TC 2mg/kg q 12 hr for 4 weeks then 4mg/kg q12 and
ZDV 4mg/kg q 12hr for 4 weeks beyond termination of
breast feeding. (Alternative to 3TC is DDI)
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B. NVP 2mg/kg qd x 14 days then 2mg/kg q 12hr and
ZDV 4mg/kg q 12hr for 4 weeks beyond termination of
breast feeding
*Emphasize importance of stopping breastfeeding, if
possible
Treatment
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Group 3: HIV infected infants < 12 months of age –
Treatment indicated in all infected infants in first year of life without regard to CD4 count.
Suggested Treatment Regimens
1 PI + 2 NRTIs
or
1 NNRTI + 2 NRTIs
First Line PI – Kaletra (LPV/rtv) – greater than 6 months. If unable to tolerate Kaletra then Nelfinavir or NNRTI are options
First Line NNRTI – Nevirapine (NVP)
First Line NRTI backbone: AZT + DDI if refrigeration is available. If not then d4T + 3TC
Note that AZT and D4T are antagonistic when given together so this combination should never be used
Group 4. HIV infected infants > 12 months of age and unable to take solid oral dosage medications
Treatment indicated if AIDS (Clinical Category C) or CD4% < 25% or HIV RNA > 100,000 copies /mL. May be indicated in other patients if HIV is
markedly symptomatic
Suggested Treatment Regimens
1 PI + 2 NRTIs
or
1 NNRTI + 2 NRTIs
First Line PI – Kaletra (LPV/rtv)
First Line NNRTI – Nevirapine (NVP)
First Line NRTI backbone AZT + DDI (if refrigeration available)
Group 5. HIV infected infants > 12 months of age and able to take solid oral dosage medications
Treatment indicated if AIDS (Clinical Category C) or CD4% < 25% or HIV RNA > 100,000 copies /mL.
Suggested Treatment Regimens
1 PI + 2 NRTIs
or
1 NNRTI + 2 NRTIs
First Line PI – Kaletra (LPV/rtv)
First Line NNRTI – Efavirenz (EFV)
Resources
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Funds for HAART for 500 HIV+ infants and children (as
per SOP) through PEPFAR
Funds for HAART for 800 HIV+ pregnant women and
ARVs for 800 newborns based on maternal history and
maternal viral load ( as per SOP and Management Plans
in progress)
Training of program staff
Funds for Laboratory testing (including DNA PCR)
through PEPFAR for 500 HIV+ infected babies, 1300
HIV+ pregnant women and their neonates to include,
HIV monitoring and resistance testing as needed.
Training needs
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Recruit and Train 2 pediatricians and 1 Ob/Gyn
physicians as needed at each site.
Training for clinic, delivery room and neonatal
nursing staff.
Train community social/outreach worker
Through SANDF staffing for MDs,
paraprofessionals and nursing and social work
case management, ancillary support services
etc.
Future
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Need statistics:
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Average number of children/Phidisa parents
enrolled
% tested and HIV+
Number of Pregnancies and deliveries per site
Data collection system to monitor toxicities in
pregnant women and newborns exposed to
HAART