Sleep and Cognition After Atripla to Stribild Switch
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|ClinicalTrials.gov Identifier: NCT02283060|
Recruitment Status : Unknown
Verified March 2016 by University of Hawaii.
Recruitment status was: Recruiting
First Posted : November 5, 2014
Last Update Posted : March 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Stribild Drug: Atripla||Phase 4|
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) and Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat) are 2 FDA-approved 'one pill once a day' combination antiretroviral medications given for the treatment of HIV. Both have a common nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir (TDF) and emtricitabine (FTC), but differ in the 3rd medication contained in the pill. Atripla contains a non-nucleoside reverse transcriptase (NNRTI) drug efavirenz (EFV) while Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat) contains an integrase inhibitor elvitegravir with the drug cobicistat inactive against HIV but designed to simply boost the level of elvitegravir.
Both drugs are reasonable well tolerated. However, efavirenz is known to cause 'mental' side-effects. It is known that the initial use of EFV is associated with central nervous system (CNS) toxicity. The symptoms of such toxicity include daytime sleepiness, or alternatively inability to sleep, as well as vivid dreams including nightmares. The majority of such symptoms are believed to resolve within weeks; however there is controversy as to whether residual problems persist on a long term basis. Furthermore there are now reports of long time cognitive dysfunction associated with the use of efavirenz. Whether this is related to sleep disturbance is not clear. Studies to assess this impact have primarily involved assessment of sleep and cognitive function in antiretroviral (ART)-naïve subjects as they are initiated on first time ART that includes EFV. Such studies however are confounded by a 'return to health' phenomena as HIV per se is known to cause sleep and cognitive deficits . There is controversy regarding whether use of efavirenz leads to long term disturbances in sleep and cognition. HIV per se causes sleep and cognitive deficits6 and studies which have tried to assess problems in antiretroviral-naïve subject's pre- and post- initiation of efavirenz-based regimens may be confounded by a 'return to health' phenomena.
This proposal aims to assess whether a switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate to elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat 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 or cognition may represent the best option to determine whether use of EFV is associated with effects on sleep and cognition beyond the immediate period following initiation of drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Change in Sleep Architecture and Neuropsychological Performance Following Switch From Atripla to Stribild.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: Stribild switch arm
Patient to be taken off Atripla and switched to Stribild (co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) -one tablet taken daily with food
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
Active Comparator: Atripla control arm
Patient to continue taking Atripla (co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate) - one tablet taken daily at bedtime on an empty stomach
To be administered orally, once daily at bedtime on an empty stomach
Other Name: Co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate
- Change in sleep architecture assessed by formal sleep study [ Time Frame: 12 weeks ]Change in sleep architecture as assessed by formal sleep study
- Change in neuropsychological performance global and subdomain neuropsychological test scores [ Time Frame: 12 weeks ]Change in global and subdomain neuropsychological test scores
- Change in Pittsburgh Sleep Quality Index Score [ Time Frame: 12 weeks ]
- Change in the frequency of use of sleep medications [ Time Frame: 12 weeks ]
- Change in the quality of life index score [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283060
|Contact: Lorna Nagamine, RNemail@example.com|
|United States, Hawaii|
|Hawaii Center for AIDS||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Lorna Nagamine 808-692-1333 firstname.lastname@example.org|
|Contact: Debbie Ogata-Arakaki 808-692-1332 email@example.com|
|Principal Investigator: Cecilia Shikuma, M.D.|
|Sub-Investigator: Bruce Soll, M.D.|
|Sub-Investigator: Dominic Chow, M.D., Ph.D.|
|Sub-Investigator: Beau Nakamoto, M.D., Ph.D.|
|Sub-Investigator: Kalpana Kallianpur, Ph.D.|
|Sub-Investigator: Tracie Umaki, Psy.D.|