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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

Sponsor
Fundacion Clinic per a la Recerca Biomédica (Other)
Overall Status
Unknown status
CT.gov ID
NCT03360682
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
32.7
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Lamivudine 300 MG
  • Drug: Abacavir 600 MG
  • Drug: Dolutegravir 50 mg
  • Drug: Tenofovir Disoproxil 245Mg Tablet
  • Drug: Emtricitabine 200 MG
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Apr 12, 2018
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

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 Names:
  • J05AF05

    • Drug: Abacavir 600 MG
    Abacavir 600 MG/day (48 weeks)
    Other Names:
  • J05AF06

    • Drug: Dolutegravir 50 mg
    Dolutegravir 50 MG/day (48 weeks)
    Other Names:
  • 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 Names:
  • J05AX12

    • Drug: Tenofovir Disoproxil 245Mg Tablet
    Tenofovir 245 MG/day (48 weeks)
    Other Names:
  • J05AF07

    • Drug: Emtricitabine 200 MG
    Emtricitabine 200 MG/day (48 weeks)
    Other Names:
  • J05AF09

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic study [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 [week 48]

      number op patients with VIH viral load > 50 copies/mL virological failure.

    2. Changes in CD4+ cell [week 48]

      To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.

    3. Lipid profile [week 48]

      To assess the changes in lipid profile (triglycerides)

    4. Renal function [week 48]

      To assess creatinine >normal valors mg/dl> 120 mg/dl

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

      number AEs and SAEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico y provincial de Barcelona Barcelona Spain 08036

    Sponsors and Collaborators

    • Fundacion Clinic per a la Recerca Biomédica

    Investigators

    • Principal Investigator: Josep M Miró Meda, MD, Hospital Clínico y provincial de Barcelona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Cruceta, Ph Md, Fundacion Clinic per a la Recerca Biomédica
    ClinicalTrials.gov Identifier:
    NCT03360682
    Other Study ID Numbers:
    • DTG-SOT
    First Posted:
    Dec 4, 2017
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Dolutegravir
    Abacavir

    Study Results

    No Results Posted as of Feb 5, 2020