Phase 4
N=19
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
HIV-1-infection · Solid Organ Transplant
Bottom Line
View on ClinicalTrials.gov: NCT03360682 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Sep 2025
Primary outcome: Primary: Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant — 825; 299; 86.5; 98.5 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lamivudine 300 MG (Drug); Abacavir 600 MG (Drug); Dolutegravir 50 mg (Drug); Tenofovir Disoproxil 245Mg Tablet (Drug); Emtricitabine 200 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant |
825; 299; 86.5; 98.5 | — |
| PRIMARY Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant |
6.3; 10.3; 1.9; 2.9 | — |
| PRIMARY Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant |
14.4; 16.4; 6.2; 4.4 | — |
| SECONDARY Viral Resistance |
— | — |
| SECONDARY Changes in CD4+ Cell |
— | — |
| SECONDARY Lipid Profile |
— | — |
| SECONDARY Renal Function |
— | — |
| SECONDARY Safety: Number AEs and SAEs |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 between determinations);
- Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03360682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.