Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2010 |
End Date: | September 2014 |
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing
fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir
disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of
care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r +
FTC/TDF was selected as the active comparator for this study as it is a preferred protease
inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral
treatment-naive adults.
fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir
disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of
care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r +
FTC/TDF was selected as the active comparator for this study as it is a preferred protease
inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral
treatment-naive adults.
Inclusion Criteria:
- Ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening
- No prior use of any approved or investigational antiretroviral drug for any length of
time
- Screening genotype report must show sensitivity to FTC, TDF, and ATV
- Normal electrocardiogram (ECG)
- Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according
to the Cockcroft Gault formula)
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) ≤ 5 x the upper limit of the normal range (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Males and Females of childbearing potential must agree to utilize highly effective
contraception methods from screening throughout the duration of study treatment and
for 30 days following the last dose of study drug
- Age ≥ 18 years
- Life expectancy ≥ 1 year
Exclusion Criteria:
- A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
the 30 days prior to screening
- Receiving drug treatment for hepatitis C, or anticipated to receive treatment for
hepatitis C
- Subjects experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- 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
- Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or
subjects with any known allergies to the excipients of Stribild tablets, Truvada
tablets, ATV capsules or ritonavir tablets
- Participation in any other clinical trial without prior approval
- 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 the dosing requirements
We found this trial at
87
sites
Annandale, Virginia 22003
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Dallas, Texas 75204
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Los Angeles, California 90028
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Tampa, Florida 33602
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