HIV-1 InfectionPhase 2PRADAIINCT02566707
Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen
A Phase 2 study testing Atazanavir, Dolutegravir and Lamivudine in people with HIV-1 Infection, run by Radboud University Medical Center at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Atazanavir, Dolutegravir and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
Rijstate
Arnhem
Radboud University Nijmegen Medical Centre
Nijmegen
St. Elisabeth
Tilburg
About this study
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
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.
- Conditions
- HIV-1 Infection
- Being tested
- Atazanavir, Dolutegravir, Lamivudine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called Reyataz
HIV therapy will be adapted: atazanavir 400mg QD
DolutegravirDrug
Also called Tivicay
HIV therapy will be adapted: dolutegravir 50mg QD
LamivudineDrug
Also called Epivir
HIV therapy will be adapted: lamivudine 300mg QD
| Study group | Role | What they receive |
|---|---|---|
| PRADAII regimen | Experimental | Use of PRADAII regimen during 12 weeks. This regimen consists of atazanavir 400 mg QD, dolutegravir 50 mg QD, lamivudine 300 mg QD. Receives: Drug: Atazanavir; Drug: Dolutegravir; Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of atazanavir, dolutegravir and lamivudine
Pharmacokinetic parameters of atazanavir, dolutegravir and lamivudine
Measured: week 2
Secondary outcomes (2)
efficacy (viral load)
efficacy (viral load) of the combination of atazanavir, dolutegravir and lamivudine
Measured: week 2, 6 and 12
number of adverse events
number of adverse events of the combination of atazanavir, dolutegravir and lamivudine
Measured: week 2, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: due to introduction of another integrase inhibitor, recruitement was not feasible anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566707
- Sponsor's protocol ID
- UMCN-AKF 14.08
- Acronym
- PRADAII
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 2015
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02566707
- Acronym / sponsor ID
- PRADAII / UMCN-AKF 14.08
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to introduction of another integrase inhibitor, recruitement was not feasible anymore.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRADAII regimen | Experimental | Drug: Atazanavir, Drug: Dolutegravir, Drug: LamivudineUse of PRADAII regimen during 12 weeks. This regimen consists of atazanavir 400 mg QD, dolutegravir 50 mg QD, lamivudine 300 mg QD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtazanavirAlso: ReyatazHIV therapy will be adapted: atazanavir 400mg QD | Drug | PRADAII regimen |
| DolutegravirAlso: TivicayHIV therapy will be adapted: dolutegravir 50mg QD | Drug | PRADAII regimen |
| LamivudineAlso: EpivirHIV therapy will be adapted: lamivudine 300mg QD | Drug | PRADAII regimen |
Primary outcome
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
2 secondary outcomes
efficacy (viral load)
Time frame: week 2, 6 and 12
number of adverse events
Time frame: week 2, 6 and 12
Results and safety
The study was stopped early (reason given: due to introduction of another integrase inhibitor, recruitement was not feasible anymore.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Abstract page 36Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atazanavir, Dolutegravir and Lamivudine in people with HIV-1 Infection, run by Radboud University Medical Center at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to introduction of another integrase inhibitor, recruitement was not feasible anymore.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of atazanavir, dolutegravir and lamivudine (time frame: week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.