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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Collaborator: INSERM UMR S 1136
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

Inclusion Criteria:

• Documented HIV-1 infection.

• Age ≥ 18 years

• Plasma HIV-RNA level ≤ 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points

• Stable antiretroviral treatment with 2 NRTI + ATV/r 300/100 for at least 6 month

• CD4+ lymphocytes > 300 cells/mm3

• Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential

• Signed informed consent

• Patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)

Exclusion Criteria:

• HIV-2 infection.

• Patient with resistant mutation for ATV and/or NRTI used on the available genotypic test

• Concomitant treatment using one or more molecules interacting with hepatic cytochromes

• Ongoing cancer. Patients with cancer considered cured for at least six months may be included.

• Active viral hepatitis C requiring a specific treatment during the 48 weeks of the trial

• hemodialysis patients

• Pregnant women, breastfeeding women or women wishing to be pregnant during the study period

• Patient with a history of non-compliance or irregular follow-up

• Subjects under "Backup justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

• Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase

• All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance

• Non-attendance which could impede the trial participation (travel abroad, moving, impending transfer...)