CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Lamivudine 300 MG +4 moredrug
Likely dose
Lamivudine 300 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03360682
NCT03360682Phase 4Completed
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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

Fundacion Clinic per a la Recerca Biomédica·interventional·Posted Dec 4, 2017·Updated Sep 30, 2025

In Brief

A Phase 4 clinical trial evaluating Lamivudine 300 MG, Abacavir 600 MG, and 3 other interventions for HIV-1-infection and Solid Organ Transplant. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection, Solid Organ Transplant
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 4, 2017
Enrollment StartApr 13, 2018
Primary CompletionMay 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.6 years ago

Interventions

Lamivudine 300 MGdrug

Lamivudine 300 MG/day (48 weeks)

Abacavir 600 MGdrug

Abacavir 600 MG/day (48 weeks)

Dolutegravir 50 mgdrug

Dolutegravir 50 MG/day (48 weeks)

Tenofovir Disoproxil 245Mg Tabletdrug

Tenofovir 245 MG/day (48 weeks)

Emtricitabine 200 MGdrug

Emtricitabine 200 MG/day (48 weeks)