A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
NCT ID: NCT00036634
Last Updated: 2014-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2002-03-31
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tenofovir DF
Participants received tenofovir DF 300 mg for 14 days
Tenofovir DF
Tenofovir DF tablet administered orally once daily
Tenofovir alafenamide 50 mg
Participants received tenofovir alafenamide 50 mg for 14 days
Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Tenofovir alafenamide 150 mg
Participants received tenofovir alafenamide 150 mg for 14 days
Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Interventions
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Tenofovir DF
Tenofovir DF tablet administered orally once daily
Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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GS-120-1101
Identifier Type: -
Identifier Source: org_study_id
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