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Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen

NCT ID: NCT02566707

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Atazanavir

Intervention Type DRUG

HIV therapy will be adapted: atazanavir 400mg QD

Dolutegravir

Intervention Type DRUG

HIV therapy will be adapted: dolutegravir 50mg QD

Lamivudine

Intervention Type DRUG

HIV therapy will be adapted: lamivudine 300mg QD

Interventions

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Atazanavir

HIV therapy will be adapted: atazanavir 400mg QD

Intervention Type DRUG

Dolutegravir

HIV therapy will be adapted: dolutegravir 50mg QD

Intervention Type DRUG

Lamivudine

HIV therapy will be adapted: lamivudine 300mg QD

Intervention Type DRUG

Other Intervention Names

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Reyataz Tivicay Epivir

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Bonn

Bonn, , Germany

Site Status

Rijstate

Arnhem, , Netherlands

Site Status

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

St. Elisabeth

Tilburg, , Netherlands

Site Status

Countries

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Germany Netherlands

Related Links

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http://regist2.virology-education.com/Abstractbook/2016_6.pdf

Abstract page 36

Other Identifiers

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UMCN-AKF 14.08

Identifier Type: -

Identifier Source: org_study_id