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Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients

NCT02473328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-08-21

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Atazanavir 200 mg/r

1. In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4), 2. switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated. The administration will be done once a day orally for 48 weeks. The usual recommended dose of atazanavir is 300 mg once daily with 100 mg of ritonavir once daily with food. Ritonavir acts by potentiating the pharmacokinetics of atazanavir.

Sponsors & Collaborators

  • INSERM UMR S 1136

    collaborator OTHER

  • Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

    lead OTHER

Principal Investigators

  • Christine Katlama, MD · Groupe Hospitalier Pitié-Salpêtrière

  • Claudine Duvivier, MD · Hôpital Necker-Enfants Malades

  • Yazdan Yazdanpanah, MD · Groupe hospitalier Bichat-Claude Bernard

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473328 on ClinicalTrials.gov