drugset / Trial / NCT03067285
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.
Timeline
- Start
- 2017-09-08
- Primary completion
- 2019-04-23
- Completion
- 2019-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ABC | Unknown | — | — |
| Subject | COBI | Unknown | — | — |
| Comparator | DTG | Unknown | — | — |
| Subject | ELV | Unknown | — | — |
| Subject | FTC | Unknown | — | — |
| Comparator | Lamivudine | Other / unclassified | — | — |
| Subject | TAF | Unknown | — | — |