Phase 3
Completed N=567
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
Source: ClinicalTrials.gov NCT02469246 ↗Enrolled (actual)
567
Serious AEs
15.3%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm — 88.6; 92.4 percentage of participants — p=0.15
◆ Published Evidence
Highly cited
160citations · ~23 / year
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.
Linked Publications (2)
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Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.
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Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm |
88.6; 92.4 | 0.15 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm |
82.1; 88.4 | 0.042 sig |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm |
1.8; 0.7 | 0.45 |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm |
2.5; 1.1 | 0.34 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm |
85.7; 87.3 | 0.62 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm |
80.4; 86.2 | 0.069 |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 48 |
-30; 2 | 0.026 sig |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
-29; 10 | 0.013 sig |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 |
0.246; 0.086 | 0.40 |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 96 |
0.169; 0.021 | 0.53 |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
0.081; -0.052 | 0.63 |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 96 |
0.178; 0.235 | 0.89 |
Eligibility Criteria
Key Inclusion Criteria
- The ability to understand and sign a written informed consent form
- On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening
- Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
- Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit
- Normal ECG
- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
Key Exclusion Criteria
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Individuals experiencing decompensated cirrhosis
- Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
- Pregnant or lactating females
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
- A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- Participation in any other clinical trial (including observational trials) without prior approval
- Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02469246) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.