Status:
UNKNOWN
Sleep and Cognition After Atripla to Stribild Switch
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 componen...
Detailed Description
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) and Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat) are 2 FDA-approved 'one pill once a day' combination ...
Eligibility Criteria
Inclusion
- 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
- 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:
- Hemoglobin \< 9.0
- Absolute neutrophil count \< 500/μL
- Platelet count \< 40,000/μL
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02283060
Start Date
September 1 2014
End Date
August 1 2016
Last Update
March 14 2016
Active Locations (1)
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1
Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96813