Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination
antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is
generally recommended in the developed world, both for its ability to reduce maternal viral
load, and thus the likelihood of transmission, as well as for its prevention of drug
resistance mutations, which might otherwise reduce future options for therapy in the mother,
infant, or both. Exclusive formula-feeding is also recommended in the developed world (where
clean water sources & adequate hygiene is reliably available) to prevent HIV transmission
through breastmilk, however, this is not yet a feasible option in many developing world
settings due to economic, infrastructure, social and infant-health reasons.
The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is
based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP;
established capsule form is known as Kaletra) to improve maternal virological control and
thus mother-to-child-transmission (MTCT).
Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir)
can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and
then subsequent complementary feeding to be carried out with minimum risk to the mother and
infant.
- Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks
gestational age (GA) and continue through labor and as long as the mother breastfeeds
- Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as
part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant
will be given as per current Zambian practice
- Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim
for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability
to wean by 13 months, however, drug will be continued until the mother has achieved a
complete wean.
- Follow-up period: Mother & child will be followed to an infant age of 24 months, as per
schedule-of-visits (approx every 3 months)
Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post
weaning.
Phase:
Phase 4
Details
Lead Sponsor:
University of Zambia
Collaborators:
Abbott University of Toronto
Treatments:
Lamivudine, zidovudine drug combination Lopinavir Ritonavir Zidovudine