A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1

This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Inclusion Criteria

• HIV-1 RNA levels greater than or equal to 30,000 copies/mL
• CD4 count greater than or equal to 200 cells/mm3
• Serum creatinine <1.5 mg/dl
• Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
• Total bilirubin less than or equal to 1.5 mg/dL
• Adequate hematologic function
• Serum amylase less than or equal to 1.5 times the upper limit of normal
• Serum phosphate greater than or equal to 2.2 mg/dL
• Not pregnant

Exclusion Criteria

• Prior treatment with antiretroviral therapy
• Immunization within 30 days of study entry
• A new AIDS defining condition within 30 days of study entry
• Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2