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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamivudine 300 mg

Drug

Lamivudine 300 MG/day (48 weeks)

Other names: J05AF05

Abacavir 600 MG

Drug

Abacavir 600 MG/day (48 weeks)

Other names: J05AF06

Dolutegravir 50 mg

Drug

Dolutegravir 50 MG/day (48 weeks)

Other names: J05AX12

Tenofovir Disoproxil 245Mg Tablet

Drug

Tenofovir 245 MG/day (48 weeks)

Other names: J05AF07

Emtricitabine 200 MG

Drug

Emtricitabine 200 MG/day (48 weeks)

Other names: J05AF09

Primary outcomes

  1. Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

    Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)

  2. Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

    Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).

  3. Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2017
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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