Back to resultsA Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tenofovir DF
Tenofovir alafenamide
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring treatment naive
Eligibility 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
Sites / Locations
- Stanford Positive Care Program
- Protocare Trials Chicago Center for Clinical Trials
- Rockefeller University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Tenofovir DF
Tenofovir alafenamide 50 mg
Tenofovir alafenamide 150 mg
Arm Description
Participants received tenofovir DF 300 mg for 14 days
Participants received tenofovir alafenamide 50 mg for 14 days
Participants received tenofovir alafenamide 150 mg for 14 days
Outcomes
Primary Outcome Measures
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Secondary Outcome Measures
Change from baseline in HIV-1 RNA (log10 copies/mL)
Change from baseline in CD4 cell count (cells/mm3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00036634
Brief Title
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
treatment naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir DF
Arm Type
Active Comparator
Arm Description
Participants received tenofovir DF 300 mg for 14 days
Arm Title
Tenofovir alafenamide 50 mg
Arm Type
Experimental
Arm Description
Participants received tenofovir alafenamide 50 mg for 14 days
Arm Title
Tenofovir alafenamide 150 mg
Arm Type
Experimental
Arm Description
Participants received tenofovir alafenamide 150 mg for 14 days
Intervention Type
Drug
Intervention Name(s)
Tenofovir DF
Other Intervention Name(s)
Viread®
Intervention Description
Tenofovir DF tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide
Other Intervention Name(s)
GS-7340
Intervention Description
Tenofovir alafenamide tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
Description
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Time Frame
Baseline to Week 2
Secondary Outcome Measure Information:
Title
Change from baseline in HIV-1 RNA (log10 copies/mL)
Time Frame
Baseline to Week 2
Title
Change from baseline in CD4 cell count (cells/mm3)
Time Frame
Baseline to Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Stanford Positive Care Program
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Protocare Trials Chicago Center for Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
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A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
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