CompletedPhase 4

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

Spain19 participantsStarted 2018-04-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT03360682

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-21

Results submitted2025-08-05

View on ClinicalTrials.gov More HIV-1-infection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

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

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