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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473328
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
INSERM UMR S 1136
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Brief 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.


Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Atazanavir 200 mg/r Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-comparative Phase II Open Study Evaluating the Efficacy of a Reduced Dose Atazanavir / Ritonavir 200/100 mg + 2 NRTI in HIV-1-infected Patients With Virological Success With Atazanavir / Ritonavir 300/100 mg + 2 NRTI
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: non comparative open study

In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4), 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.

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.

Other Name: ritonavir 100mg




Primary Outcome Measures :
  1. Measure of effectiveness assessed by maintaining undetectable plasma HIV viral load (viral load ≤ 50 copies / ml) during the all period of this study of treatment with ATV / r 200/100 mg + 2 NRTIs, for all patients. [ Time Frame: one year ]
  2. Measure of safety (adverse events) [ Time Frame: one year ]
    Number of participant with adverse events

  3. Measure of tolerability assessed by number of patient interrupting the study treatment for virological failure [ Time Frame: one year ]
  4. Measure of effectiveness assessed by number of patient maintaining a target trough plasma concentration of atazanavir associated to efficacy: [ Time Frame: one year ]
    Residual plasma concentrations of ATV / r (Dates and last dose of antiretroviral schedules and the association or not with food ) will be performed at day 0 before changing dose reduction of atazanavir, week 12 and week 24 for all patients.

  5. Measure of effectiveness assessed in patient with virological failure number of patient dysplaing HIV strains with mutations associated to treatment resistance [ Time Frame: one year ]
  6. Measure of tolerability assessed by number of patient interrupting the study treatment for in tolerance [ Time Frame: one year ]
  7. Measure of tolerability assessed by quantification of bilirubinemia [ Time Frame: one year ]
  8. Measure of tolerability assessed by quantification of creatininemia [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473328


Locations
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France
DUDOIT Yasmine
Paris, France, 75013
Sponsors and Collaborators
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
INSERM UMR S 1136
Investigators
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Principal Investigator: Christine Katlama, MD Groupe Hospitalier Pitié-Salpêtrière
Principal Investigator: Claudine Duvivier, MD Hôpital Necker-Enfants Malades
Principal Investigator: Yazdan Yazdanpanah, MD Groupe hospitalier Bichat-Claude Bernard
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Responsible Party: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier: NCT02473328    
Other Study ID Numbers: CREPATS 003
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Keywords provided by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida:
dose reduction study
Additional relevant MeSH terms:
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Ritonavir
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors