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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Positive, Antiretroviral Treatment- Naive Adults

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Positive, Antiretroviral Treatment- Naive Adults

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222080
Enrollment
840
Registered
2013-05-14
Start date
2013-05-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection

Interventions

investigational material(s) Generic name etc : EVG/COBI/FTC/TAF INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mater

Sponsors

JAPAN TABACCO INC.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Plasma HIV-1 RNA level is 1,000 copies/mL or above at screening Screening genotype report demonstrating sensitivity to EVG, FTC, and TDF Estimated glomerular filtration rate is 50 mL/min or above according to the Cockcroft-Gault formula for creatinine clearance

Exclusion criteria

Exclusion criteria: A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening Hepatitis B surface antigen (HBsAg) positive Hepatitis C antibody positive

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026