Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to understand and sign a written informed consent form
Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug for any length of time
Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)
Normal ECG
Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
CD4+ cell count \> 50 cells/µL
Serum amylase ≤ 5 x ULN
Normal thyroid-stimulating hormone (TSH)
Females of childbearing potential must have a negative serum pregnancy test
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
Female subjects 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
Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
Female subjects 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 test at screening
Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product
Age ≥ 18 years
Life expectancy ≥ 1 year
You may not be if
New AIDS-defining condition diagnosed within the 30 days prior to screening
Hepatitis B surface Antigen positive
Hepatitis C Antibody positive
Proven acute hepatitis in the 30 days prior to study entry
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
Current alcohol or substance
History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma or resected, non-invasive 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 is prohibited while participating in this trial
Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC 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
