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

Phase 2CompletedNCT00036634

Gilead Sciences30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections

Interventions

Tenofovir DFDRUG

Tenofovir DF tablet administered orally once daily

Tenofovir alafenamideDRUG

Tenofovir alafenamide tablet(s) administered orally once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 2

Secondary Outcomes

Change from baseline in HIV-1 RNA (log10 copies/mL)

Time frame: Baseline to Week 2

Change from baseline in CD4 cell count (cells/mm3)

Time frame: Baseline to Week 2

Data from ClinicalTrials.gov

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