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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

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