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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; Solid Organ Transplant
• Intervention / Treatment: Drug: Lamivudine 300 MG; Drug: Abacavir 600 MG; Drug: Dolutegravir 50 mg; Drug: Tenofovir Disoproxil 245Mg Tablet; Drug: Emtricitabine 200 MG

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
5. Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV-1-infected solid organ transplant patients 1; The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus. treatment 48 weeks	Drug: Lamivudine 300 MG; Lamivudine 300 MG/day (48 weeks); Other Names: J05AF05; Drug: Abacavir 600 MG; Abacavir 600 MG/day (48 weeks); Other Names: J05AF06; Drug: Dolutegravir 50 mg; Dolutegravir 50 MG/day (48 weeks); Other Names: J05AX12
Experimental: HIV-1-infected solid organ transplant patients 2; The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus. treatment 48 weeks	Drug: Dolutegravir 50 mg; Dolutegravir 50 MG/day (48 weeks); Other Names: J05AX12; Drug: Tenofovir Disoproxil 245Mg Tablet; Tenofovir 245 MG/day (48 weeks); Other Names: J05AF07; Drug: Emtricitabine 200 MG; Emtricitabine 200 MG/day (48 weeks); Other Names: J05AF09

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant	Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)	24-hours before the switch and 24-hours 2 weeks after switching
Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant	Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).	24-hours before the switch and 24-hours 2 weeks after switching
Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant		24-hours before the switch and 24-hours 2 weeks after switching

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Resistance	number op patients with VIH viral load > 50 copies/mL virological failure.	week 48
Changes in CD4+ Cell	To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood.	week 48
Lipid Profile	To assess the changes in lipid profile (triglycerides)	week 48
Renal Function	To assess creatinine >normal valors mg/dl> 120 mg/dl	week 48
Safety: Number AEs and SAEs	number AEs and SAEs	week 48

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: Josep M Miró Meda, MD, Hospital Clínico y Provincial de Barcelona

Publications and helpful links

Helpful Links

• PMCID: PMC12007624

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Actual): May 21, 2020
• Study Completion (Actual): May 21, 2020

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Dosage Forms; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Organophosphorus Compounds; Nucleosides; Deoxyribonucleosides; Organophosphonates; Adenine; Dideoxynucleosides; Zalcitabine; Tenofovir; Emtricitabine; Lamivudine; Tablets; dolutegravir; abacavir
• Other Study ID Numbers: DTG-SOT; 2017-000469-62 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No