Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Cluster of differentiation 4 (CD4) cell count \> 50 cells/µL
Normal thyroid-stimulating hormone
Negative serum pregnancy test (females of childbearing potential only)
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs
Age ≥ 18 years
Life expectancy ≥ 1 year
You may not be if
New AIDS-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or primary PI resistance mutation(s)
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Participants experiencing cirrhosis
Participants experiencing ascites
Participants experiencing encephalopathy
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Vaccinated within 90 days of study dosing
History or family history of Long QT Syndrome or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 years
Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)
PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening
QRS greater than or equal to 120 msec on ECG at screening
Implanted defibrillator or pacemaker
Subjects receiving ongoing therapy with any disallowed medications
Current alcohol or substance use judged to potentially interfere with subject study compliance
History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval
Medications contraindicated for use with ATV, RTV, FTC, or TDF
Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or FTC/TDF tablets
Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
Clareo Health | Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
