A phase 3, randomized, double-blind study to evaluate the safety and efficacy of GS-9350-boosted Atazanavir versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults.
- Conditions
- Human Immunodeficiency Virus (HIV-1) Infections10047438
- Registration Number
- NL-OMON38379
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
* 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 provided by Gilead Sciences must show sensitivity to FTC,
TDF and ATV
* Adequate renal function: Estimated glomerular filtration rate * 70 mL/min according to the Cockcroft-Gault formula.
* Hepatic transaminases (AST and ALT) * 5 × upper limit of normal (ULN)
* Total bilirubin * 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function (absolute neutrophil count * 1,000/mm3; platelets
* 50,000/mm3; hemoglobin * 8.5 g/dL)
* Serum amylase * 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible
if serum lipase is * 5 × ULN)
* Age * 18 years
* Life expectancy * 1 year
* A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening
* Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to
receive treatment for Hepatitis C during the course of the study.
* Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
* Have an implanted defibrillator or pacemaker
* Have an ECG PR interval * 220 msec
* Current alcohol or substance use judged by the Investigator to potentially interfere with
subject study compliance.
* A history of malignancy within the past 5 years (prior to screening) or ongoing
malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or
resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are
eligible, but must not have received any systemic therapy for KS within 30 days of
Baseline and must not be anticipated to require systemic therapy during the study.
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or
antifungal therapy within 30 days prior to Baseline.
* Subjects receiving ongoing therapy with any of the medications as listed in the protocol v 15Mar2010.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: The primary efficacy endpoint is the proportion of subjects that<br /><br>achieve HIV 1 RNA < 50 copies/mL at Week 48 as defined by the Food and Drug<br /><br>Administration (FDA) snapshot analysis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The proportion of subjects with HIV 1 RNA < 50 copies/mL at Week 96, 144 and<br /><br>192 as defined by the FDA snapshot analysis<br /><br>The change from baseline in CD4+ cell count at Weeks 48, 96, 144 and 192.<br /><br><br /><br>Safety: Adverse events and clinical laboratory tests to evaluate the safety and<br /><br>tolerability of the treatment regimens.</p><br>