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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

NCT03360682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-09-30

Study results available
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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.

Conditions

Interventions

DRUG

Lamivudine 300 MG

Lamivudine 300 MG/day (48 weeks)

DRUG

Abacavir 600 MG

Abacavir 600 MG/day (48 weeks)

DRUG

Dolutegravir 50 mg

Dolutegravir 50 MG/day (48 weeks)

DRUG

Tenofovir Disoproxil 245Mg Tablet

Tenofovir 245 MG/day (48 weeks)

DRUG

Emtricitabine 200 MG

Emtricitabine 200 MG/day (48 weeks)

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Josep M Miró Meda, MD · Hospital Clínico y provincial de Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2020-05-21
Completion
2020-05-21

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360682 on ClinicalTrials.gov