Status:
COMPLETED
Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Lead Sponsor:
Gilead Sciences
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvit...
Eligibility Criteria
Inclusion
- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
- No prior use of any approved or experimental anti-HIV drug
- Normal electrocardiogram (ECG)
- Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
- Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Cluster determinant 4 (CD4) cell count \> 50 cells/µL
- Serum amylase ≤ 1.5 x ULN
- Normal thyroid-stimulating hormone
- Negative serum pregnancy test (for females of childbearing potential only)
- Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
- Life expectancy ≥ 1 year
- Ability to understand and sign a written informed consent form
Exclusion
- New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
- Hepatitis B surface antigen positive
- Hepatitis C antibody positive
- Participants experiencing cirrhosis
- Participants experiencing ascites
- Participants experiencing encephalopathy
- Females who are breastfeeding
- Positive serum pregnancy test (for females of childbearing potential)
- Vaccinated within 90 days of study dosing
- History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
- Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
- Prolonged QTcF interval at screening
- PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
- QRS ≥ 120 msec on ECG at screening
- Implanted defibrillator or pacemaker
- Participants receiving ongoing therapy with any disallowed medications
- Current alcohol or substance use judged to potentially interfere with participant study compliance
- History of or ongoing malignancy (including untreated carcinoma in situ) 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
- Participation in any other clinical trial without prior approval
- Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
- Any known allergies to the excipients of Atripla or Stribild tablets
- Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00869557
Start Date
April 1 2009
End Date
September 1 2013
Last Update
June 4 2014
Active Locations (30)
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1
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States, 72207
2
The Living Hope Foundation
Long Beach, California, United States, 90813
3
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
4
Orange Coast Medical Group
Newport Beach, California, United States, 92663