Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:March 27, 2013
End Date:March 2019

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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

This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide
(TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil
fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected
participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.


Key Inclusion Criteria:

- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures

- Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF,
RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final
visit in their earlier study

- Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103,
GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only
participants on an EFV-based regimen), or completion of studies GS-US-236-0104,
GS-US-216-0105

- Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive
months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening
visit

- Normal echocardiograph (ECG)

- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance

- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of the normal range (ULN)

- Direct bilirubin ≤ 1.5 x ULN

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Females of childbearing potential must agree to utilize highly effective contraception
methods or be non-heterosexually active or practice sexual abstinence from screening
throughout the duration of study treatment and for 12 weeks following the last dose of
study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all
other regimens.

- Female participants who utilize hormonal contraceptive as one of their birth control
methods must have used the same method for at least three months prior to study dosing

- Female participants who have stopped menstruating for ≥ 12 months but do not have
documentation of ovarian hormonal failure must have a serum follicle stimulating
hormone (FSH) level at screening within the post-menopausal range based on the Central
Laboratory reference range

Key Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to screening

- Hepatitis B surface antigen position

- Hepatitis C antibody positive

- Participants experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the subject unsuitable for the study or unable to comply with
dosing requirements

- Participation in any other clinical trial without prior approval from the sponsor is
prohibited while participating in this trial

- Participants receiving ongoing therapy with drugs not to be used with elvitegravir
(EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies
to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
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Phoenix, Arizona 85006
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1720 2nd Ave S
Birmingham, Alabama 35233
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4025 North Sheridan Road
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707 Hollybrook Drive
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4600 N Habana Ave # 23
Tampa, Florida 33614
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47 New Scotland Ave
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1400 Pelham Parkway South
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Chapel Hill, North Carolina 27599
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5 Richland Medical Park Dr
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1001 E 5th St
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8701 W Watertown Plank Rd
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1020 Walnut St
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3451 Walnut St
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2315 Stockton Blvd.
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Saint Louis, Missouri 63108
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