Phase 3
N=881
Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT02345226 ↗Enrolled (actual)
881
Serious AEs
10.9%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm — 90.0; 92.0 percentage of participants — p=0.35
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FTC/RPV/TAF (Drug); EFV/FTC/TDF Placebo (Drug); EFV/FTC/TDF (Drug); FTC/RPV/TAF Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jun 2016
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 |
90.0; 92.0 | 0.35 |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm |
1.1; 0.9 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm |
0.7; 0.9 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot |
85.2; 85.1 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 48 |
23; 12 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 96 |
12; 6 | — |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 |
1.279; -0.134 | — |
| SECONDARY Percent Change From Baseline in Hip BMD at Week 96 |
1.831; -0.617 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 48 |
1.645; -0.045 | — |
| SECONDARY Percent Change From Baseline in Spine BMD at Week 96 |
1.701; 0.126 | — |
| SECONDARY Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48 |
0; -1 | — |
| SECONDARY Change From Baseline in HIVSI Score at Week 96 |
0; -1 | — |
Summary
The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.
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 EFV/FTC/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. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
- Have no documented resistance to any of the study agents at any time in the past
- 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 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 the 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 protocol defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02345226). 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.