A clinical research study involving an experimental drug named Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen and Tenofovir Alafenamide single agent. This study evaluates if TAF single agent is effective against HIV-1 infected subjects when added to subject’s current antiretroviral regimen that is no longer effective to treat HIV-1 and if subjects can safely switch to E/C/F/TAF STR plus Atazanavir without increasing the amount of virus in their blood.
- Conditions
- HIV-1 InfectionMedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-002830-19-GB
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
-Age = 18 years of age at Screening
-Estimated glomerular filtration rate (Cockcroft Gault equation) = 50 mL/min
-HIV-1 RNA = 500 copies/mL but =100,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
-Currently taking a failing ARV regimen
-Screening and historical genotype report (if available) showing either 1 to 3 thymidine-analogue mutations (TAMs) or K65R as well as M184V, and at least one primary NNRTI and/or one primary PI mutation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Screening and historical genotype reports (if available) shows Q151M, T69ins, or more than 3 thymidine-analogue mutations (TAMs) in RT, or I50L, I84V, N88S in PR.
-Patients with Q151M or T69ins present on screening or historical genotype
-History of integrase strand transfer inhibitor (INSTI) use
-Evidence of chronic viral Hepatitis B or C infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method