Phase 3
Completed N=632
Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Source: ClinicalTrials.gov NCT02345252 ↗Enrolled (actual)
632
Serious AEs
9.9%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm — 93.7; 93.9 percentage of participants — p=1.00
◆ Published Evidence
Established
76citations · ~8 / year
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
Summary
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
Linked Publications (2)
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Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
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Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
93.7; 93.9 | 1.00 |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
0.6; 0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
0.6; 1.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
89.2; 88.5 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
9; -1 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 |
12; 16 | — |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 |
1.040; -0.245 | — |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 96 |
1.623; -0.613 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
1.613; 0.075 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 96 |
2.039; -0.250 | — |
Eligibility Criteria
Key Inclusion Criteria
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- Currently receiving FTC/RPV/TDF FDC for ≥ 6 consecutive months preceding the screening visit
- Documented plasma HIV-1 RNA levels 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
- Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (1.17 mL/sec) according to the Cockcroft-Gault formula
Key Exclusion Criteria
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)
- Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Current alcohol or substance use judged by the Investigator to potentially interfere with individual's 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. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
- 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 from the sponsor is prohibited while participating in this trial
- Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals with any known allergies to the excipients of FTC/RPV/TAF
Note: Other Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02345252) 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.