Phase 3
Completed N=167
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
Source: ClinicalTrials.gov NCT02616783 ↗Enrolled (actual)
167
Serious AEs
6.6%
Results posted
Feb 2019
Primary outcomePrimary: Percent Change From Baseline to Week 48 in Spine BMD — 2.237; -0.104 Percent change — p=<0.001
◆ Published Evidence
Established
43citations · ~6 / year
Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial.
Summary
The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.
Linked Publications
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Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 48 in Spine BMD |
2.237; -0.104 | <0.001 sig |
| PRIMARY Percent Change From Baseline to Week 48 in Hip BMD |
1.330; -0.726 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 24 in Spine BMD |
1.625; -0.027 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 24 in Hip BMD |
0.808; -0.537 | <0.001 sig |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm |
94.5; 100.0 | 0.18 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm |
93.6; 94.5 | 1.00 |
| SECONDARY Change From Baseline in CD4+ Cell Count at Week 24 |
48; -4 | 0.053 |
| SECONDARY Change in Baseline in CD4+ Cell Count at Week 48 |
56; -1 | 0.051 |
Eligibility Criteria
Key Inclusion Criteria
- Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For individuals with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.
Refer to assigned interventions for allowed third agents of the current regimen.
- Documented plasma HIV-1 RNA levels 50 and < 400 copies/mL) is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the "blip".
- Plasma HIV-1 RNA level < 50 copies/mL at screening visit
- Adequate renal function
- Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
- All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to first ART is not available or individual has 3 or more ART regimens, individuals will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
- Study performed dual energy x-ray absorptiometry (DXA) scan and T-score received prior to Day 1
Key Exclusion Criteria
- Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
- Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV)
- A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
- Hepatitis C virus that would require therapy during the study
- Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02616783) 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.