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. DGT-SOT

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 - DTG-SOT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000469-62-ES

Enrollment

Registered

2017-06-16

Start date

2017-07-24

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infected solid organ transplant patients MedDRA version: 20.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10057925 Term: Transplant evaluation System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Triumeq® Product Name: Triumeq 50 mg/600 mg/300 mg comprimidos recubiertos con película dolutegravir/abacavir/lamivudina Pharmaceutical Form: Coated tablet INN or Proposed INN: dolutegravi

Eligibility

Sex/Gender

All

Inclusion 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 ART for =6 months preceding the screening visit; 5. Plasma HIV RNA 50 between determinations); 6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aims of this study are to obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients To provide proof of principle data that DTG plus 2 NUCs is safe and effective in HIV-infected SOT recipients.;Secondary Objective: 1. To assess the development of viral resistance in subjects experiencing virological failure; 2. To assess the changes in CD4+ cell count in peripheral blood; 3. To assess the changes in lipid profile (triglycerides, total, LDL- and HDL-cholesterol); 4. To assess renal function in HIV SOT patients.;Primary end point(s): 1. To obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients; 2. To provide proof of principle data that DTG plus 2 NRTIs is safe and effective in HIV-infected SOT recipients. (numer AES, SAEs related treatment and CD4 cels;Timepoint(s) of evaluation of this end point: Interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) Susars, SAEs, Death	—

Measure

Time frame

Main Objective: The aims of this study are to obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients To provide proof of principle data that DTG plus 2 NUCs is safe and effective in HIV-infected SOT recipients.;Secondary Objective: 1. To assess the development of viral resistance in subjects experiencing virological failure; 2. To assess the changes in CD4+ cell count in peripheral blood; 3. To assess the changes in lipid profile (triglycerides, total, LDL- and HDL-cholesterol); 4. To assess renal function in HIV SOT patients.;Primary end point(s): 1. To obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients; 2. To provide proof of principle data that DTG plus 2 NRTIs is safe and effective in HIV-infected SOT recipients. (numer AES, SAEs related treatment and CD4 cels;Timepoint(s) of evaluation of this end point: Interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) Susars, SAEs, Death

—

Secondary

Measure	Time frame
Secondary end point(s): To assess the development of viral resistance in subjects experiencing virological failure; 2. To assess the changes in CD4+ cell count in peripheral blood;w 48 3. To assess the changes in lipid profile (triglycerides, total, LDL- and HDL-cholesterol); w 48 4. To assess renal function in HIV SOT patients.w 48;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Spain

Contacts

Public ContactCTU

CTU Clinic (clinical Trial Unit)

acruceta@clinic.ub.es+349322754009838

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026