HIV-1-infectionPhase 4NCT03360682

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

A Phase 4 study testing Lamivudine 300 MG, Abacavir 600 MG and Dolutegravir 50 mg in people with HIV-1-infection and Solid Organ Transplant, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection, Solid Organ Transplant
What is being tested?: Lamivudine 300 MG, Abacavir 600 MG and Dolutegravir 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteSpain
Study dates: 13 Apr 2018to 21 May 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínic de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

Official title: 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

Conditions: HIV-1-infection, Solid Organ Transplant
Being tested: Lamivudine 300 MG, Abacavir 600 MG, Dolutegravir 50 mg, Tenofovir Disoproxil 245Mg Tablet, Emtricitabine 200 MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lamivudine 300 MGDrug
Also called J05AF05
Lamivudine 300 MG/day (48 weeks)
Abacavir 600 MGDrug
Also called J05AF06
Abacavir 600 MG/day (48 weeks)
Dolutegravir 50 mgDrug
Also called J05AX12
Dolutegravir 50 MG/day (48 weeks)
Tenofovir Disoproxil 245Mg TabletDrug
Also called J05AF07
Tenofovir 245 MG/day (48 weeks)
Emtricitabine 200 MGDrug
Also called J05AF09
Emtricitabine 200 MG/day (48 weeks)

Study groups in NCT03360682
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Dolutegravir 50 mg; Drug: Tenofovir Disoproxil 245Mg Tablet; Drug: Emtricitabine 200 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant
Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)
Measured: 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).
Measured: 24-hours before the switch and 24-hours 2 weeks after switching
Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant
Measured: 24-hours before the switch and 24-hours 2 weeks after switching

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201821 May 2020

First posted4 Dec 2017
Study start13 Apr 2018
Primary completion21 May 2020
Study completion21 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360682
Sponsor's protocol ID: DTG-SOT
Other IDs: 2017-000469-62, 2017
Status last verified: Sep 2025
First submitted: 30 Oct 2017
Last updated: 30 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03360682
Acronym / sponsor ID: DTG-SOT
Conditions: HIV-1-infection, Solid Organ Transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
Study start: 13 Apr 2018 (actual)
Primary completion: 21 May 2020 (actual)
Study completion: 21 May 2020 (actual)
First posted: 4 Dec 2017 (actual)
Results: Posted 30 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HIV-1-infected solid organ transplant patients 1	Experimental	Drug: Lamivudine 300 MG, Drug: Abacavir 600 MG, Drug: Dolutegravir 50 mgThe 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
HIV-1-infected solid organ transplant patients 2	Experimental	Drug: Dolutegravir 50 mg, Drug: Tenofovir Disoproxil 245Mg Tablet, Drug: Emtricitabine 200 MGThe 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lamivudine 300 MGAlso: J05AF05Lamivudine 300 MG/day (48 weeks)	Drug	HIV-1-infected solid organ transplant patients 1
Abacavir 600 MGAlso: J05AF06Abacavir 600 MG/day (48 weeks)	Drug	HIV-1-infected solid organ transplant patients 1
Dolutegravir 50 mgAlso: J05AX12Dolutegravir 50 MG/day (48 weeks)	Drug	HIV-1-infected solid organ transplant patients 1, HIV-1-infected solid organ transplant patients 2
Tenofovir Disoproxil 245Mg TabletAlso: J05AF07Tenofovir 245 MG/day (48 weeks)	Drug	HIV-1-infected solid organ transplant patients 2
Emtricitabine 200 MGAlso: J05AF09Emtricitabine 200 MG/day (48 weeks)	Drug	HIV-1-infected solid organ transplant patients 2

Primary outcome

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

5 secondary outcomes

Viral Resistance
Time frame: week 48
Changes in CD4+ Cell
Time frame: week 48
Lipid Profile
Time frame: week 48
Renal Function
Time frame: week 48
Safety: Number AEs and SAEs
Time frame: week 48

Results and safety

Results posted to the registry on 30 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DTG + 2 NRTIs	19	16

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

Time frame: 24-hours before the switch and 24-hours 2 weeks after switching. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Pharmacokinetic (PK) Subset Before ART Change n = 2	Pharmacokinetic (PK) Subset After 2wk ART Change n = 2
Cmax	825 (686 to 946)	299 (120 to 478)
Cmin	86.5 (83 to 90)	98.5 (65 to 132)

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

Time frame: 24-hours before the switch and 24-hours 2 weeks after switching. Median (Inter-Quartile Range). Unit: μg/mL

Measure	Pharmacokinetic (PK) Subset Before ART Change n = 7	Pharmacokinetic (PK) Subset After 2wk ART Change n = 7
Cmax	6.3 (3.8 to 10.7)	10.3 (5.3 to 12.9)
Cmin	1.9 (1.5 to 2.5)	2.9 (1.7 to 4)

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

Time frame: 24-hours before the switch and 24-hours 2 weeks after switching. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Pharmacokinetic (PK) Subset Before ART Change n = 7	Pharmacokinetic (PK) Subset After 2wk ART Change n = 7
Cmax	14.4 (10.8 to 18.3)	16.4 (12.1 to 18.7)
Cmin	6.2 (5.2 to 8.9)	4.4 (4.3 to 8.5)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 48 weeks of treatment plus 28 days after last dose in case of early withdrawal.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTG + 2 NRTIs	1 of 19 (5.3%)	15 of 19 (78.9%)	0 of 19

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
PMCID: PMC12007624Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for HIV-1-infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Josep M Miró Meda, MD principal investigator

Hospital Clínico y provincial de Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant (time frame: 24-hours before the switch and 24-hours 2 weeks after switching). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.