- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03360682
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients
February 4, 2020 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients
The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08036
- Hospital Clinico y Provincial de Barcelona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV patients >18 years old who provide signed and dated informed consent;
- Males and females;
- SOT recipients (heart, liver or kidney);
- On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
- Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
- Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
Exclusion Criteria:
- HIV patients who have stopped ART due to virological failure;
- HIV patients who require treatment with DTG contraindicated medications;
- History or presence of an allergy or intolerance to the study drug;
- Active opportunistic infection;
- Neoplasms requiring chemotherapy.
- Pregnancy or breast feeding or planned pregnancy during the study period
- Any other contraindication to study drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIV-1-infected solid organ transplant patients 1
The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus. treatment 48 weeks |
Lamivudine 300 MG/day (48 weeks)
Other Names:
Abacavir 600 MG/day (48 weeks)
Other Names:
Dolutegravir 50 MG/day (48 weeks)
Other Names:
|
Experimental: HIV-1-infected solid organ transplant patients 2
The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus. treatment 48 weeks |
Dolutegravir 50 MG/day (48 weeks)
Other Names:
Tenofovir 245 MG/day (48 weeks)
Other Names:
Emtricitabine 200 MG/day (48 weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic study
Time Frame: 24-hours before the switch and 24-hours 2 weeks after switching
|
"Peak Plasma Concentration (Cmax) mg /mL of dolutegravir.
|
24-hours before the switch and 24-hours 2 weeks after switching
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral resistance
Time Frame: week 48
|
number op patients with VIH viral load > 50 copies/mL virological failure.
|
week 48
|
Changes in CD4+ cell
Time Frame: week 48
|
To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.
|
week 48
|
Lipid profile
Time Frame: week 48
|
To assess the changes in lipid profile (triglycerides)
|
week 48
|
Renal function
Time Frame: week 48
|
To assess creatinine >normal valors mg/dl> 120 mg/dl
|
week 48
|
Safety: number AEs and SAEs
Time Frame: week 48
|
number AEs and SAEs
|
week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Josep M Miró Meda, MD, Hospital Clinico y Provincial de Barcelona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2018
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
December 1, 2017
First Posted (Actual)
December 4, 2017
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Tenofovir
- Emtricitabine
- Lamivudine
- Dolutegravir
- Abacavir
Other Study ID Numbers
- DTG-SOT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV-1-infection
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Helios SaludViiV HealthcareUnknownHiv | HIV-1-infectionArgentina
-
Frontier Biotechnologies Inc.RecruitingHIV-1-infectionUnited States
-
University of ZurichActive, not recruitingHIV-1-infectionSwitzerland
-
MacroGenicsNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV-1-infectionUnited States
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades...Aelix TherapeuticsCompleted
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV-1 InfectionUnited States
-
Taipei Veterans General Hospital, TaiwanCompleted
-
Shanghai Public Health Clinical CenterUnknown
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades...Completed
Clinical Trials on Lamivudine 300 MG
-
ViiV HealthcareGlaxoSmithKlineCompletedInfection, Human Immunodeficiency VirusUnited States
-
Shanghai Public Health Clinical CenterNot yet recruitingAcquired Immunodeficiency Syndrome
-
Thomas BenfieldRecruitingHIV Infections | Obesity | Renal Insufficiency | Osteoporosis | Hiv | Weight Gain | HIV LipodystrophyDenmark
-
Makerere UniversityMassachusetts General HospitalCompletedPrEP | HIV | Sexually Transmitted Infections | Transgender MenUganda
-
Obafemi Awolowo UniversityLondon School of Hygiene and Tropical Medicine; University of California, San... and other collaboratorsCompletedHuman Immunodeficiency Virus InfectionNigeria
-
University Hospital, CaenMerck Sharp & Dohme LLCNot yet recruiting
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedHealthy Subjects | Infection, Human Immunodeficiency VirusUnited States
-
ViiV HealthcareGlaxoSmithKline; ShionogiCompletedInfection, Human Immunodeficiency VirusUnited States
-
Bausch Health Americas, Inc.CompletedRheumatoid ArthritisUnited States
-
Novartis PharmaceuticalsCompletedChronic Plaque PsoriasisUnited States