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

Study Overview
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Brief Summary
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This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tenofovir DF
* Drug: Tenofovir alafenamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenofovir DF<br>Participants received tenofovir DF 300 mg for 14 days | Drug: Tenofovir DF<br>* Tenofovir DF tablet administered orally once daily<br>* Other names: Viread®;|
| Experimental: Tenofovir alafenamide 50 mg<br>Participants received tenofovir alafenamide 50 mg for 14 days | Drug: Tenofovir alafenamide<br>* Tenofovir alafenamide tablet(s) administered orally once daily<br>* Other names: GS-7340;|
| Experimental: Tenofovir alafenamide 150 mg<br>Participants received tenofovir alafenamide 150 mg for 14 days | Drug: Tenofovir alafenamide<br>* Tenofovir alafenamide tablet(s) administered orally once daily<br>* Other names: GS-7340;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HIV-1 RNA (log10 copies/mL) |  | Baseline to Week 2 | 
| Change from baseline in CD4 cell count (cells/mm3) |  | Baseline to Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment naive