Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only
present condition to prevent the progression of the disease, improve immune restoration and
prevent the emergence of viral resistance mutations. In addition to the individual benefit,
antiretroviral treatment reduces the transmission of HIV from an infected person to sexual
partners. There is to date no alternative strategy to antiretroviral treatment and
antiretroviral therapy, even extended, does not allow viral eradication.
The need to maintain antiretroviral therapy for life raises the long-term safety concerns of
it, even with the latest molecules. Also, one of the key issues in clinical research is
whether after reaching undetectable viral load, antiretroviral treatment can be reduced in
order to reduce exposure to molecules. Indeed, this treatment of "maintenance" could
potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral
treatment reduces costs, an important consideration in light of new global recommendations of
treatment for all patients with T-cells CD4 below 500 / mm3.
The alleviation of antiretroviral therapy is to either reduce the number of molecules by
making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce
the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of
Efavirenz 400mg instead of 600mg in naive patients.
Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with
two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable
viral load.
Phase:
Phase 2
Details
Lead Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida