Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
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|ClinicalTrials.gov Identifier: NCT01815736|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Results First Posted : April 14, 2016
Last Update Posted : March 1, 2019
|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|
|Actual Primary Completion Date :||March 16, 2015|
|Estimated Study Completion Date :||March 2019|
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®
Efavirenz (EFV)/FTC/TDF (600/200/300 mg) FDC tablet administered orally once daily
Other Name: Atripla®
Ritonavir (RTV) 100 mg tablet administered orally once daily
Other Name: Norvir®
Atazanavir (ATV) 300 mg capsule administered orally once daily
Other Name: Reyataz®
Emtricitabine (FTC)/TDF (200/300 mg) tablet administered orally once daily
Other Name: Truvada®
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815736
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|Study Director:||Gilead Study Director||Gilead Sciences|