Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
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, which must be obtained prior to initiation of study procedures
Currently taking a failing ARV regimen
Plasma HIV-1 RNA ≥ 500 copies/mL but ≤ 100,000 copies/mL at screening
Normal ECG
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Alanine aminotransferase (AST)/aspartate aminotransferase (AST) ≤ 5 × the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Females may enter the study if it is confirmed that she is:
* Not pregnant or nursing
* Of non-childbearing potential (ie, have had a hysterectomy, both ovaries removed, medically documented ovarian failure, or are postmenopausal women \> 54 years of age with cessation \[for ≥ 12 months\] of previously occurring menses), or
* Of childbearing potential and agrees 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 study drug dosing
* 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.
Males must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
Males must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.
You may not be if
A new AIDS-defining condition diagnosed within the 30 days prior to screening
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody positive (individuals with positive hepatitis C virus (HCV) antibody and without detectable HCV RNA are permitted to enroll)
History of integrase inhibitor use
Screening or historical genotype reports shows Q151M or T69ins or more than 3 TAMs.
Screening or historical genotype report shows resistance to integrase inhibitors
Individuals experiencing decompensated cirrhosis
Current alcohol or substance use
History of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Part 1, Day 1 and must not be anticipated to require systemic therapy during the study.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Part 1, Day 1
Any other clinical condition or prior therapy that 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 from the sponsor is prohibited while participating in this trial
Receiving ongoing therapy with any disallowed medications, including any drugs not to be used with elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or known allergies to the excipients of E/C/F/TAF STR
