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

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00036634

Run by

Gilead Sciences

People needed

30

Starts

2002-03-01

Expected to finish

2003-02-01

Last updated by the study team

2014-01-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Positive Care Program — Palo Alto, California, United States
• Protocare Trials Chicago Center for Clinical Trials — Chicago, Illinois, United States
• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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