HIV-1 Infection Clinical Trial
Official title:
Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
In pregnancy, cART is considered optimal for maternal health and for preventing the
emergence of resistance that could compromise further care. In Canada, the majority of
HIV-positive pregnant women receive a PI-based cART regimen. In the past, therapy was
generally deferred until after the first trimester (if not required for maternal health) to
minimize any unknown risk of teratogenicity. However, as treatment is now started earlier in
HIV infection and as perinatal transmission rates are lowest in those with prolonged
suppression of viral load during pregnancy, women are increasingly commencing cART either
before conception or earlier in pregnancy.
Multiple reports and cohort studies provided data suggesting an association between PI-based
cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies,
although conflicting data exist.
In the general population progesterone supplementation is widely used, is well tolerated, is
considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth
weight. The investigators experimental findings suggest that PI use during pregnancy is
associated with declines in progesterone levels that correlate with fetal growth, and that
progesterone supplementation can improve PI-induced fetal growth restriction. The
investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated
with declines in progesterone levels, which correlate with birth weight percentile. Since
HIV-positive women have higher rates of pre-term delivery and low birth weight that may be
magnified by the use of PIs, then progesterone supplementation could be of benefit to
neonatal health in the context of HIV-positive pregnancy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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