Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

HIV

HIV Infections

Treatments

Drug: Atripla

Drug: Stribild

Study type

Interventional

Funder types

Industry

Identifiers

NCT00869557

GS-US-236-0104

Details and patient eligibility

About

The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.

Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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