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
Adult (≥ 18 years) males or non-pregnant females
Ability to understand and sign a written informed consent form
General medical condition which does not interfere with the assessments and the completion of the trial
Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
CD4+ cell count \> 50 cells/µL
Treatment-naive: No prior use of any approved or experimental anti-HIV drug for any length of time
Screening genotype report must show sensitivity to DRV, TDF and 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 normal (ULN)
Total bilirubin ≤ 1.5 mg/dL
Serum amylase ≤ 5 x ULN
Adequate hematologic function
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 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
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
You may not be if
A 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
Have a history or experiencing decompensated cirrhosis
Current alcohol or substance use that potentially interferes with study compliance
Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
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
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
Have an implanted defibrillator or pacemaker
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
Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with darunavir and cobicistat
Note: darunavir is a sulfonamide. Participants who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and darunavir has been identified in patients participating in Phase 2 and Phase 3 trials.
Clareo Health | D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
