Sleep and Cognition After Atripla to Stribild Switch

NCT02283060 | Unknown Phase 4

• 1 other identifier: H027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

Atripla; Stribild; HIV; Sleep architecture; Neuropsychological performance

Outcome Measures

Primary Outcomes (2)

• Change in sleep architecture assessed by formal sleep study

  Change in sleep architecture as assessed by formal sleep study

  12 weeks

• Change in neuropsychological performance global and subdomain neuropsychological test scores

  Change in global and subdomain neuropsychological test scores

  12 weeks

Secondary Outcomes (3)

• Change in Pittsburgh Sleep Quality Index Score

  12 weeks

• Change in the frequency of use of sleep medications

  12 weeks

• Change in the quality of life index score

  12 weeks

Study Arms (2)

Stribild switch arm

EXPERIMENTAL

Patient to be taken off Atripla and switched to Stribild (co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) -one tablet taken daily with food

Drug: Stribild

Atripla control arm

ACTIVE COMPARATOR

Patient to continue taking Atripla (co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate) - one tablet taken daily at bedtime on an empty stomach

Drug: Atripla

Interventions

Stribild DRUG

To be administered orally, once daily with food.

Also known as: Co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate

Stribild switch arm

Atripla DRUG

To be administered orally, once daily at bedtime on an empty stomach

Also known as: Co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate

Atripla control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Age 18 to 65 years
• On stable efavirenz/emtricitabine/tenofovir disoproxil fumarate regimen \> 12 months
• Documented plasma HIV RNA \< 50 copies/ml within 3 months of entry
• Ability and willingness to provide written informed consent

You may not qualify if:

• Receipt of any other antiretroviral drugs in addition to efavirenz/emtricitabine/tenofovir disoproxil fumarate within 6 months of study entry
• Any documented plasma HIV RNA \> 100 copies/ml within the past 6 months prior to study entry
• Chronic hepatitis B as assessed by positive hepatitis B surface antigen \[HBsAg\]
• Chronic hepatitis C as assessed by positive hepatitis C antibody \[HCVab\], except with proof of viral clearance and normal liver function tests
• Other chronic disease which is uncontrolled or likely to interfere with study results
• Acute illness within 2 weeks of entry
• Previously documented history of OSA (obstructive sleep apnea)
• Moderate to high risk of OSA defined as BMI (Body mass index) \> 30 plus two of the following: habitual snoring, gasping/choking, observed apnea while sleeping, neck circumference \> 17 inches
• Severe depression based on the BDI-2 (Beck Depression Inventory - II)
• Chronic daily receipt of medications associated with potential for sleep interference (i.e. psychoactive drugs, steroids, decongestants, beta blockers)
• Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
• Anticipated need for medications which are contraindicated as per Stribild package insert
• Any known contra-indication to use of Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat)
• Creatinine clearance (Cockcroft and Gault) \< 70 ml/min
• The following lab values:

Sponsors & Collaborators

• University of Hawaii: lead
• Gilead Sciences: collaborator

Study Sites (1)

Hawaii Center for AIDS

Honolulu, Hawaii, 96813, United States

RECRUITING

MeSH Terms

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Oxazines

Central Study Contacts

Lorna Nagamine, RN

CONTACT

808-692-1333; lornan@hawaii.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

US (1)