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Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen (PRADAII)

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ClinicalTrials.gov Identifier: NCT02566707
Recruitment Status : Terminated (due to introduction of another integrase inhibitor, recruitement was not feasible anymore.)
First Posted : October 2, 2015
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
During the past years the treatment of HIV-1 infection has transformed towards chronic treatment. Patients are being treated with antiretroviral drugs for many years and become older. The risk of developing side-effects due to long term antiretroviral therapy is therefore more and more likely. New alternative once-daily maintenance regimes are needed for those who are extensively pre-treated and experience side-effects or toxicity on standard treatment combinations. A possible once-daily, fully active maintenance regimen is the combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen). This combination is expected to be a safe, once-daily maintenance regimen with a favorable side-effect profile. The combination suits patients with intolerance and/or resistance to NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new combination the pharmacokinetic profile is unknown and there are no data on short-term and long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety and efficacy in a small number of HIV-1 infected patients.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Atazanavir Drug: Dolutegravir Drug: Lamivudine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Safety and Efficacy of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen in Patients With Intolerance and/or Resistance to NRTIs, NNRTIs and RTV: A Pilot Study
Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PRADAII regimen
Use of PRADAII regimen during 12 weeks. This regimen consists of atazanavir 400 mg QD, dolutegravir 50 mg QD, lamivudine 300 mg QD.
Drug: Atazanavir
HIV therapy will be adapted: atazanavir 400mg QD
Other Name: Reyataz

Drug: Dolutegravir
HIV therapy will be adapted: dolutegravir 50mg QD
Other Name: Tivicay

Drug: Lamivudine
HIV therapy will be adapted: lamivudine 300mg QD
Other Name: Epivir




Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of atazanavir, dolutegravir and lamivudine [ Time Frame: week 2 ]
    Pharmacokinetic parameters of atazanavir, dolutegravir and lamivudine


Secondary Outcome Measures :
  1. efficacy (viral load) [ Time Frame: week 2, 6 and 12 ]
    efficacy (viral load) of the combination of atazanavir, dolutegravir and lamivudine

  2. number of adverse events [ Time Frame: week 2, 6 and 12 ]
    number of adverse events of the combination of atazanavir, dolutegravir and lamivudine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
  • Subject is in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance.
  • Subject is at least 18 years of age at the day of screening.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy prior to inclusion.
  • Subject has no documented resistance mutations to PIs, INSTIs or lamivudine.

Exclusion Criteria:

  • Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
  • Abnormal serum transaminases determined as levels being > 5 times upper limit of normal.
  • Renal failure determined as an estimated Glomerular Filtration Rate (eGFR) < 50 ml/min (MDRD-based).
  • Concomitant use of medications that interfere with atazanavir, dolutegravir or lamivudine pharmacokinetics: oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John's wort, rifampicin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, buprenorphine, aprepitant, modafinil, imatinib, co-trimoxazole, other antiretroviral drugs.
  • Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, dofetilide, pimozide, quetiapine, quinidine, bepridil, simvastatin, atorvastatin, lovastatin, sildenafil (as for use in pulmonary arterial hypertension), cladribine.
  • Active hepatobiliary or hepatic disease (including chronic hepatitis B or C infection).
  • Alcohol abuse.

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): NCT02566707


Locations
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Germany
University of Bonn
Bonn, Germany
Netherlands
Rijstate
Arnhem, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
St. Elisabeth
Tilburg, Netherlands
Sponsors and Collaborators
Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02566707     History of Changes
Other Study ID Numbers: UMCN-AKF 14.08
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Lamivudine
Atazanavir Sulfate
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors