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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

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ClinicalTrials.gov Identifier: NCT03360682
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Solid Organ Transplant Drug: Lamivudine 300 MG Drug: Abacavir 600 MG Drug: Dolutegravir 50 mg Drug: Tenofovir Disoproxil 245Mg Tablet Drug: Emtricitabine 200 MG Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Drug: Lamivudine 300 MG
Lamivudine 300 MG/day (48 weeks)
Other Name: J05AF05
Drug: Abacavir 600 MG
Abacavir 600 MG/day (48 weeks)
Other Name: J05AF06
Drug: Dolutegravir 50 mg
Dolutegravir 50 MG/day (48 weeks)
Other Name: J05AX12
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

Drug: Dolutegravir 50 mg
Dolutegravir 50 MG/day (48 weeks)
Other Name: J05AX12
Drug: Tenofovir Disoproxil 245Mg Tablet
Tenofovir 245 MG/day (48 weeks)
Other Name: J05AF07
Drug: Emtricitabine 200 MG
Emtricitabine 200 MG/day (48 weeks)
Other Name: J05AF09



Primary Outcome Measures :
  1. Pharmacokinetic study [ Time Frame: 24-hours before the switch and 24-hours 2 weeks after switching ]
    "Peak Plasma Concentration (Cmax) mg /mL of dolutegravir.


Secondary Outcome Measures :
  1. Viral resistance [ Time Frame: week 48 ]
    number op patients with VIH viral load > 50 copies/mL virological failure.

  2. Changes in CD4+ cell [ Time Frame: week 48 ]
    To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.

  3. Lipid profile [ Time Frame: week 48 ]
    To assess the changes in lipid profile (triglycerides)

  4. Renal function [ Time Frame: week 48 ]
    To assess creatinine >normal valors mg/dl> 120 mg/dl

  5. Safety: number AEs and SAEs [ Time Frame: week 48 ]
    number AEs and SAEs



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

Inclusion Criteria:

  1. HIV patients >18 years old who provide signed and dated informed consent;
  2. Males and females;
  3. SOT recipients (heart, liver or kidney);
  4. On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
  5. Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
  6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing

Exclusion Criteria:

  1. HIV patients who have stopped ART due to virological failure;
  2. HIV patients who require treatment with DTG contraindicated medications;
  3. History or presence of an allergy or intolerance to the study drug;
  4. Active opportunistic infection;
  5. Neoplasms requiring chemotherapy.
  6. Pregnancy or breast feeding or planned pregnancy during the study period
  7. Any other contraindication to study drugs.

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): NCT03360682


Contacts
Contact: Anna Cruceta Arboles, MD +34 93 2275400 ext 4380 acruceta@clinic.ub.es

Locations
Spain
Hospital Clínico y provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Anna Cruceta Arboles, MD    +34 93 2275400 ext 4380    acruceta@clinic.ub.es   
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: Josep M Miró Meda, MD Hospital Clínico y provincial de Barcelona

Responsible Party: Anna Cruceta, Ph Md, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03360682     History of Changes
Other Study ID Numbers: DTG-SOT
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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