Intervention: Stribild
Trial phase: Phase 2
SMILES: CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.CC(C)c1nc(CN(C)C(=O)NC(CCN2CCOCC2)C(=O)NC(CCC(Cc2ccccc2)NC(=O)OCc2cncs2)Cc2ccccc2)cs1.COc1cc2c(cc1Cc1cccc(Cl)c1F)c(=O)c(C(=O)O)cn2C(CO)C(C)C.Nc1nc(=O)n(C2CSC(CO)O2)cc1F.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Stribild and placebo to match Atripla were administered during the double-blind phase.
Eligibility criteria:
Inclusion Criteria:

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug
Normal electrocardiogram (ECG)
Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Cluster determinant 4 (CD4) cell count > 50 cells/µL
Serum amylase ≤ 1.5 x ULN
Normal thyroid-stimulating hormone
Negative serum pregnancy test (for 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 12 weeks following the last dose of study drugs
Life expectancy ≥ 1 year
Ability to understand and sign a written informed consent form

Exclusion Criteria:

New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor 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 (for females of childbearing potential)
Vaccinated within 90 days of study dosing
History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
Prolonged QTcF interval at screening
PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
QRS ≥ 120 msec on ECG at screening
Implanted defibrillator or pacemaker
Participants receiving ongoing therapy with any disallowed medications
Current alcohol or substance use judged to potentially interfere with participant 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 EFV, EVG, COBI, FTC, or TDF
Any known allergies to the excipients of Atripla or Stribild tablets
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements