Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
|ClinicalTrials.gov Identifier: NCT01815736|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Results First Posted : April 14, 2016
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: E/C/F/TAF Drug: E/C/F/TDF Drug: EFV/FTC/TDF Drug: RTV Drug: ATV Drug: FTC/TDF Drug: COBI||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1443 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects|
|Actual Study Start Date :||March 27, 2013|
|Primary Completion Date :||March 16, 2015|
|Estimated Study Completion Date :||June 2018|
Participants will switch to E/C/F/TAF FDC tablet for up to 96 weeks in the Randomized Phase, and may continue treatment with E/C/F/TAF in the open-label Extension Phase.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered orally once daily
Other Name: Genvoya®
Active Comparator: Stay on Baseline Treatment Regimen (SBR)
Participants will stay on their baseline FTC/tenofovir disoproxil fumarate (TDF)-containing regimen (either E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF) for up to 96 weeks in the Randomized Phase, and may switch to E/C/F/TAF in the open-label Extension Phase.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) FDC tablet administered orally once daily
Other Name: Stribild®Drug: EFV/FTC/TDF
Efavirenz (EFV)/FTC/TDF (600/200/300 mg) FDC tablet administered orally once daily
Other Name: Atripla®Drug: RTV
Ritonavir (RTV) 100 mg tablet administered orally once daily
Other Name: Norvir®Drug: ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®Drug: FTC/TDF
Emtricitabine (FTC)/TDF (200/300 mg) tablet administered orally once daily
Other Name: Truvada®Drug: COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
- Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ]Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
- Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
- Change From Baseline in Serum Creatinine at Week 48 [ Time Frame: Baseline; Week 48 ]
- Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48 [ Time Frame: Baseline; Week 48 ]
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).
EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815736
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|Study Director:||Gilead Study Director||Gilead Sciences|