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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

October 30, 2017
December 4, 2017
December 4, 2017
January 2018
January 2020   (Final data collection date for primary outcome measure)
Pharmacokinetic study [ Time Frame: 24-hours before the switch and 24-hours 2 weeks after switching ]
"Peak Plasma Concentration (Cmax) mg /mL of dolutegravir.
Same as current
No Changes Posted
  • Viral resistance [ Time Frame: week 48 ]
    number op patients with VIH viral load > 50 copies/mL virological failure.
  • Changes in CD4+ cell [ Time Frame: week 48 ]
    To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.
  • Lipid profile [ Time Frame: week 48 ]
    To assess the changes in lipid profile (triglycerides)
  • Renal function [ Time Frame: week 48 ]
    To assess creatinine >normal valors mg/dl> 120 mg/dl
  • Safety: number AEs and SAEs [ Time Frame: week 48 ]
    number AEs and SAEs
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV-1-infection
  • Solid Organ Transplant
  • 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
  • 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
  • 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

    Interventions:
    • Drug: Lamivudine 300 MG
    • Drug: Abacavir 600 MG
    • Drug: Dolutegravir 50 mg
  • 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

    Interventions:
    • Drug: Dolutegravir 50 mg
    • Drug: Tenofovir Disoproxil 245Mg Tablet
    • Drug: Emtricitabine 200 MG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Same as current
January 2020
January 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Anna Cruceta Arboles, MD +34 93 2275400 ext 4380 acruceta@clinic.ub.es
Spain
 
 
NCT03360682
DTG-SOT
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Fundacion Clinic per a la Recerca Biomédica
Not Provided
Principal Investigator: Josep M Miró Meda, MD Hospital Clínico y provincial de Barcelona
Fundacion Clinic per a la Recerca Biomédica
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP