Phase 4
Completed 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
Source: ClinicalTrials.gov NCT03360682 ↗
Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Sep 2025
Primary outcomePrimary: Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant — 825; 299; 86.5; 98.5 ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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. Informational only — not medical advice.