CClinicalTrials.gg
Sign In
CompletedNCT03360682Updated Sep 30, 2025Results posted

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 interventional study of Lamivudine 300 MG and Abacavir 600 MG in HIV-1-infection and Solid Organ Transplant, sponsored by Fundacion Clinic per a la Recerca Biomédica. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Fundacion Clinic per a la Recerca Biomédica · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV-1-infection
  • Solid Organ Transplant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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 · Drug: Abacavir 600 MG · Drug: Dolutegravir 50 mg

  • 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 · Drug: Tenofovir Disoproxil 245Mg Tablet · Drug: Emtricitabine 200 MG

Interventions

  • DrugLamivudine 300 MG

    Lamivudine 300 MG/day (48 weeks)

    Also known as: J05AF05

  • DrugAbacavir 600 MG

    Abacavir 600 MG/day (48 weeks)

    Also known as: J05AF06

  • DrugDolutegravir 50 mg

    Dolutegravir 50 MG/day (48 weeks)

    Also known as: J05AX12

  • DrugTenofovir Disoproxil 245Mg Tablet

    Tenofovir 245 MG/day (48 weeks)

    Also known as: J05AF07

  • DrugEmtricitabine 200 MG

    Emtricitabine 200 MG/day (48 weeks)

    Also known as: J05AF09

05

What researchers measure

Primary outcomes

  1. Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant

    Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

  2. Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant

    Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

  3. Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant

    Time frame: 24-hours before the switch and 24-hours 2 weeks after switching

Secondary outcomes

  1. Viral Resistance

    number op patients with VIH viral load \> 50 copies/mL virological failure.

    Time frame: week 48

  2. Changes in CD4+ Cell

    To assess the changes in CD4+ cell count \>200 cel/mL in peripheral blood.

    Time frame: week 48

  3. Lipid Profile

    To assess the changes in lipid profile (triglycerides)

    Time frame: week 48

  4. Renal Function

    To assess creatinine \>normal valors mg/dl\> 120 mg/dl

    Time frame: week 48

  5. Safety: Number AEs and SAEs

    number AEs and SAEs

    Time frame: week 48

06

Results

Posted Sep 30, 2025
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.

Participant flow

Participant flow — Overall Study
MilestoneDTG + 2 NRTIs
Started19
Completed16
Not completed3
Withdrew: Adverse event3

Outcome measures

PrimaryChange in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant

Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)

Time frame:
24-hours before the switch and 24-hours 2 weeks after switching
Reported as:
Median · ng/mL
Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant
ng/mLPharmacokinetic (PK) Subset Before ART ChangePharmacokinetic (PK) Subset After 2wk ART Change
Cmax825 (686 to 946)299 (120 to 478)
Cmin86.5 (83 to 90)98.5 (65 to 132)
SecondaryViral Resistance

number op patients with VIH viral load \> 50 copies/mL virological failure.

Time frame:
week 48

Results for this outcome have not been posted.

SecondaryChanges in CD4+ Cell

To assess the changes in CD4+ cell count \>200 cel/mL in peripheral blood.

Time frame:
week 48

Results for this outcome have not been posted.

SecondaryLipid Profile

To assess the changes in lipid profile (triglycerides)

Time frame:
week 48

Results for this outcome have not been posted.

SecondaryRenal Function

To assess creatinine \>normal valors mg/dl\> 120 mg/dl

Time frame:
week 48

Results for this outcome have not been posted.

SecondarySafety: Number AEs and SAEs

number AEs and SAEs

Time frame:
week 48

Results for this outcome have not been posted.

PrimaryChange in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant

Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).

Time frame:
24-hours before the switch and 24-hours 2 weeks after switching
Reported as:
Median · μg/mL
Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant
μg/mLPharmacokinetic (PK) Subset Before ART ChangePharmacokinetic (PK) Subset After 2wk ART Change
Cmax6.3 (3.8 to 10.7)10.3 (5.3 to 12.9)
Cmin1.9 (1.5 to 2.5)2.9 (1.7 to 4)
PrimaryChange in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant
Time frame:
24-hours before the switch and 24-hours 2 weeks after switching
Reported as:
Median · ng/mL
Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant
ng/mLPharmacokinetic (PK) Subset Before ART ChangePharmacokinetic (PK) Subset After 2wk ART Change
Cmax14.4 (10.8 to 18.3)16.4 (12.1 to 18.7)
Cmin6.2 (5.2 to 8.9)4.4 (4.3 to 8.5)

Adverse events

Collected over Up to 48 weeks of treatment plus 28 days after last dose in case of early withdrawal.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DTG + 2 NRTIs0/19 (0%)1/19 (5.3%)15/19 (78.9%)
Most frequent serious events
Most frequent serious events
EventDTG + 2 NRTIs
Cytomegalovirus infectionInfections and infestations1/19
Most frequent other events
Most frequent other events
EventDTG + 2 NRTIs
OtherGeneral disorders10/19
DiarrheaGastrointestinal disorders3/19
InsomniaNervous system disorders1/19
TremorNervous system disorders1/19
Anxiety symptomsNervous system disorders1/19
HyperglycemiaEndocrine disorders1/19

Baseline characteristics

Age, Continuous
Age, Continuous(years)DTG + 2 NRTIs
Median57 (51 to 60)
Sex: Female, Male
Sex: Female, Male(Participants)DTG + 2 NRTIs
Female8
Male11
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DTG + 2 NRTIs
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported19
07

Study locations

1 site
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 8, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03360682
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Responsible party
Sponsor
First posted
Dec 4, 2017
Start date
Apr 13, 2018
Primary completion
May 21, 2020
Completion
May 21, 2020
Results posted
Sep 30, 2025
Last update
Sep 30, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Fundacion Clinic per a la Recerca Biomédica

Start the discussion