drugset / Trial / NCT02283060

Sleep and Cognition After Atripla to Stribild Switch

NCT02283060

Phase 4 Unknown 30 enrolled University of Hawaii Gilead Sciences · collab
RandomizedParallel-groupOpen-labelSupportive care

Summary

Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral medications given for the treatment of HIV. Both drugs are reasonably well tolerated. However, efavirenz, a component of Atripla, is known to cause "mental" side effects. This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep and cognition may represent the best option to determine whether use of efavirenz is associated with effects on sleep and cognition beyond the immediate period following initiation of drug.

Timeline

Start
2014-09
Primary completion
2016-07
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atripla Unknown Oral
Subject Stribild Other / unclassified Oral