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 | Completed Phase 4 Results

• 2 other identifiers: DTG-SOT2017-000469-62
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 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

HIV-1-infection; Solid Organ Transplant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Viral Resistance

  week 48

• Changes in CD4+ Cell

  week 48

• Lipid Profile

  week 48

• Renal Function

  week 48

• Safety: Number AEs and SAEs

  week 48

Study Arms (2)

HIV-1-infected solid organ transplant patients 1

EXPERIMENTAL

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; Drug: Abacavir 600 MG; Drug: Dolutegravir 50 mg

HIV-1-infected solid organ transplant patients 2

EXPERIMENTAL

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; Drug: Tenofovir Disoproxil 245Mg Tablet; Drug: Emtricitabine 200 MG

Interventions

Lamivudine 300 MG DRUG

Lamivudine 300 MG/day (48 weeks)

Also known as: J05AF05

HIV-1-infected solid organ transplant patients 1

Abacavir 600 MG DRUG

Abacavir 600 MG/day (48 weeks)

Also known as: J05AF06

HIV-1-infected solid organ transplant patients 1

Dolutegravir 50 mg DRUG

Dolutegravir 50 MG/day (48 weeks)

Also known as: J05AX12

HIV-1-infected solid organ transplant patients 1; HIV-1-infected solid organ transplant patients 2

Tenofovir Disoproxil 245Mg Tablet DRUG

Tenofovir 245 MG/day (48 weeks)

Also known as: J05AF07

HIV-1-infected solid organ transplant patients 2

Emtricitabine 200 MG DRUG

Emtricitabine 200 MG/day (48 weeks)

Also known as: J05AF09

HIV-1-infected solid organ transplant patients 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Links

• PMCID: PMC12007624

MeSH Terms

Interventions

Lamivudine; abacavir; dolutegravir; Tenofovir; Tablets; Emtricitabine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

The study was a single-arm pilot trial with a small sample size, which may limit generalizability. The number of participants included in the pharmacokinetic analysis of cyclosporine A was limited, and therefore insufficient to support robust statistical conclusions. No control group was included, and all participants received DTG-based ART. Further studies are needed to confirm findings in larger cohorts.

Results Point of Contact

• Title: Jose M. Miro Meda (PI), MD, PhD, Consultant, Infectious Diseases Service
• Organization: Hospital Clínic/IDIBAPS, University of Barcelona

JMMIRO@clinic.cat

93 227 54 30

Study Officials

• Josep M Miró Meda, MD

  Hospital Clínico y provincial de Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 4, 2017
• Study Start: April 13, 2018
• Primary Completion: May 21, 2020
• Study Completion: May 21, 2020
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)