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

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:

  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.

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:
  • J05AF05
Abacavir 600 MG/day (48 weeks)
Other Names:
  • J05AF06
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

Dolutegravir 50 MG/day (48 weeks)
Other Names:
  • J05AX12
Tenofovir 245 MG/day (48 weeks)
Other Names:
  • J05AF07
Emtricitabine 200 MG/day (48 weeks)
Other Names:
  • J05AF09

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

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.

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