Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: E/C/F/TDF Placebo
  • drug: E/C/F/TAF Placebo
  • drug: E/C/F/TAF
  • drug: E/C/F/TDF

Eligibility


Key Inclusion Criteria:

   - Ability to understand and sign a written informed consent form, which must be obtained
   prior to initiation of study procedures

   - Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

   - No prior use of any approved or investigational antiretroviral drug for any length of
   time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis
   (PEP) up to 6 months prior to screening

   - Screening genotype report must show sensitivity to elvitegravir, emtricitabine,
   tenofovir DF

   - Normal electrocardiogram (ECG)

   - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
   Cockcroft-Gault formula for creatinine clearance

   - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)

   - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

   - Adequate hematologic function

   - Serum amylase ≤ 5 × ULN

   - Males and females of childbearing potential must agree to utilize highly effective
   contraception methods or be non-heterosexually active or practice sexual abstinence
   from screening throughout the duration of study treatment and for 30 days following
   the last dose of study drug

   - Females who utilize hormonal contraceptive as one of their birth control methods must
   have used the same method for at least three months prior to study dosing

   - Females who have stopped menstruating for ≥ 12 months but do not have documentation of
   ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at
   screening within the post-menopausal range based on the Central Laboratory reference
   range

   - Age ≥ 18 years

Key Exclusion Criteria:

   - A new AIDS-defining condition diagnosed within the 30 days prior to screening

   - Hepatitis B surface antigen (HBsAg) positive

   - Hepatitis C antibody positive

   - Individuals experiencing decompensated cirrhosis

   - Females who are breastfeeding

   - Positive serum pregnancy test

   - Have an implanted defibrillator or pacemaker

   - Current alcohol or substance use judged by the Investigator to potentially interfere
   with study compliance

   - History of malignancy within the past 5 years or ongoing malignancy 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

   - Any other clinical condition or prior therapy that, in the opinion of the
   Investigator, would make the individual unsuitable for the study or unable to comply
   with dosing requirements

   - Participation in any other clinical trial (including observational trials) without
   prior approval

   - Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat,
   emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the
   excipients of E/C/F/TDF or E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
650-723-2804
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.