Clinical research study involving an experimental combination medication called EVG/COBI/FTC/TDF. This is 1 pill containing 2 experimental medications, EVG and COBI, plus 2 medications already approved for the treatment of HIV-1 infection, FTC and TDF. In this study neither the patient or the investigator will know whether the patient is receiving EVG/COBI/FTC/TDF or the comparator drug ritonavir-boosted atazanavir with FTC/TDF.
- Conditions
- Human Immunodeficiency Virus (HIV-1) Infections.MedDRA version: 15.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003708-11-IT
- Lead Sponsor
- GILEAD SCIENCE INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 510
- Female (at birth), age = 18 years; -Plasma HIV-1 RNA levels = 500 copies/mL at screening; -Adequate renal function: Estimated glomerular filtration rate = 70 mL/min according to the Cockcroft-Gault formula; -No prior use of any approved or experimental antiretroviral drug for any length of time; -Screening genotype report shows sensitivity to FTC, TDF and ATV/r; -Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 484
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
- A new AIDS-defining condition 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.). - Females who are breastfeeding. - Positive serum pregnancy test (female of childbearing potential). - 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. - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. - 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method