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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
 
Region Sponsors
California - Northern
Gilead Sciences
 
Acronym KP IRB No.
CN-15-2504-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with HIV-1 Infection
 
Purpose
This study will evaluate the efficacy of a fixed dose combination (FDC) containing GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults at Week 48.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Antiretroviral treatment naive (= 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening
  • Plasma HIV 1 RNA levels = 500 copies/mL at screening
  • Adequate renal function: Estimated glomerular filtration rate = 30 mL/min (= 0.50 mL/sec) according to the Cockcroft Gault formula
 
Exclusion Criteria
  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • Females who are pregnant (as confirmed by positive serum pregnancy test)
  • Females who are breastfeeding

 
Keywords and/or Specific Medical Conditions
  • Anti-HIV Agents
  • HIV Integrase Inhibitors
  • Anti-Infective Agents
  • Integrase Inhibitors
  • Anti-Retroviral Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antiviral Agents
  • Nucleic Acid Synthesis Inhibitors
  • Dolutegravir
  • Reverse Transcriptase Inhibitors
  • Emtricitabine
  • Tenofovir
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • HIV-1
  • Enzyme Inhibitors
  • Infectious Diseases
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
Daniel Klein, MD
Contact Information:
- Catherine Vowles
-catherine.vowles@kp.org
-San Francisco Medical Center


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