HIV-1 Infection MedDRA version: 17.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Tenofovir alafenamide
Product Code: GS-7340
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tenofovir Alafenamide
CAS Number: 379270-37-8
Current Sponsor code: GS-7340
Other
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 124 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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 stand transfer inhibitor (INSTI) use -Evidence of chronic viral Hepatitis B or C infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral regimen, as demonstrated by the proportion of subjects with HIV-1 RNA decreases from baseline exceeding 0.5 log10 after 10 days of therapy in HIV-1 positive, antiretroviral treatment experienced adult subjects.;Secondary Objective: To evaluate the efficacy of TAF as demonstrated by the reduction in HIV-1 RNA at Day 10 To evaluate the efficacy and safety of elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide single tablet regimen (E/C/F/TAF STR) plus atazanavir after 24 weeks of treatment in subjects switched from a failing regimen as determined by the achievement of plasma HIV-1 RNA <50 copies/mL. To evaluate the efficacy and safety of E/C/F/TAF STR plus atazanavir after 48 weeks of treatment in subjects switched from a failing regimen.;Primary end point(s): The proportion of subjects with plasma HIV-1 RNA decreases from baseline exceeding 0.5 log10 at Day 10 in Part 1.;Timepoint(s) of evaluation of this end point: Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -The change from baseline in plasma log10 HIV-1 RNA (copies/mL) at Day 10 in Part 1. -The percentage of subjects with plasma HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot analysis at Weeks 24 and 48. -The percentage of subjects with plasma HIV-1 RNA < 400 copies/mL as defined by the FDA snapshot analysis at Weeks 24 and 48. -The change from baseline in plasma log10 HIV-1 RNA (copies/mL) and in CD4+ cell count (cells/µL) and percentage at Week 24. -The change from baseline in plasma log10 HIV-1 RNA (copies/mL) and in CD4+ cell count (cells/µL) and percentage at Week 48. -The safety of E/C/F/TAF STR plus ATV in subjects switched from a failing regimen after 24 and 48 weeks of treatment as assessed by laboratory parameters and adverse events during the study. -The following PK parameters of TAF, TFV, EVG and ATV will be calculated for subjects in the intensive PK substudies, as appropriate: AUClast , Clast and Cmax for TAF and AUCtau, Ctau, and Cmax for TFV, EVG and ATV.;Timepoint(s) of evaluation of this end point: Day 10 week 48 | — |
Countries
Australia, Canada, Dominican Republic, Germany, Poland, Russian Federation, South Africa, Thailand, Uganda, United Kingdom, United States
Contacts
Public ContactMedical Monitor
Gilead Sciences, Inc.
Outcome results
None listed