Sleep and Cognition After Atripla to Stribild Switch

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Hawaii
• Collaborator: Gilead Sciences
• Treatments: Cobicistat; Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Hemoglobin < 9.0

2. Absolute neutrophil count < 500/μL

3. Platelet count < 40,000/μL

4. AST (SGOT) and ALT (SGPT) > 5x ULN

• Active or recent past history (within past 5 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements

• Pregnancy or breast-feeding, intent to become pregnant during the course of the study or breast-feeding

• Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable