Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02283060
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02283060
Study Brief:
Protocol Section:
NCT02283060