Status:
COMPLETED
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
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
HIV-1-infection
Solid Organ Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03360682
Start Date
April 13 2018
End Date
May 21 2020
Last Update
September 30 2025
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036