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
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female (at birth), age ≥ 18 years
Ability to understand and sign a written informed consent form
Plasma HIV-1 RNA levels ≥ 500 copies/mL
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)
Normal ECG
Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL
Adequate hematologic function
Serum amylase ≤ 5 x ULN
Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
Women 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.
You may not be if
A new AIDS defining condition diagnosed within the 30 days
Females receiving drug treatment for Hepatitis C, or females who are anticipated to receive treatment for Hepatitis C during the course of the study
Females experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Have an ECG pulse rate interval ≥ 220 msec
Current alcohol or substance use which may potentially interfere with the female's study compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval
Any other clinical condition or prior therapy that would make the female unsuitable for the study or unable to comply with the dosing requirements
Females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets
Clareo Health | Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
