Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
The current available antiretroviral (ARV) agents make possible a successful treatment of
virtually all HIV-infected patients, even those heavily experienced subjects, with a history
of previous failure to ARV drugs of different classes. However, some problems are still
present, especially for specific populations, like pregnant women and infants. For these
groups, most of currently available drugs are not used, because the lack of information on
safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child
transmission (MTCT) is still a problem in certain areas of the world, especially in
resource-limited settings. In some settings, women often present to their first antenatal
care visit late in the pregnancy, posing an additional problem: how to effectively treat
these patients to assure they will have an undetectable viral load at the moment of
delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6
or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA /
ml of plasma. To achieve this goal, it would be necessary the use of a potent, very
efficacious ARV regimen that could provide such viral decay in a very short period.
Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The
available evidence suggest it has no genotoxic potential, and promotes a rapid decline in
HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting
different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to
be used for prevention of MTCT for women with detectable viral load, presenting late in the
course of pregnancy. Another attractive point is to consider that, due to the similarity
between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1);
RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct,
the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has
the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1
RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters
pregnant women and to compare the frequency of adverse events for women using RAL-based ARV
regimens and comparators, and for their babies.