Human Immunodeficiency Virus, Type 1 (HIV-1) Infection MedDRA version: 17.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Stribild
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Elvitegravir
CAS Number: 697761-98-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The ability to understand and sign a written informed consent form (ICF) • Treatment naïve • Plasma HIV-1 RNA levels = 5,000 copies/mL at screening • CD4 cell count > 200 cells/µL • Screening genotype report provided by the site must show sensitivity to FTC, TDF, EFV, ABC, 3TC, ATV and absence of study drug resistance mutations that include K65R, K70E and M184V in RT • Estimated GFR = 70 mL/min according to the Cockcroft Gault formula for creatinine clearance (CLcr) • Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN) • Total bilirubin = 1.5 mg/dL ( 5 × ULN will remain eligible if serum lipase is = 5 × ULN) • Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) • A female subject is eligible to enter the study if it is confirmed that she is (as defined in the protocol): not pregnant or non-lactating; of non-childbearing potential; of childbearing potential and agrees 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 if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose. • Female patients 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 • Male patients must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose • Male patients must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose. • 18- 55 years of age, inclusive • Body mass index (BMI) of 19 = BMI = 30 kg/m2 and body weight ? 40 kg • Life expectancy = 1 year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who are HLA-B*5701 allele positive • A new AIDS-defining condition diagnosed within the 30 days prior to screening • Hepatitis B surface antigen (HBsAg) positive • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable • Patients experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.) • Females who are breastfeeding • Positive serum pregnancy test (females of childbearing potential) • Have an implanted defibrillator or pacemaker • 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. Patients with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 Visit 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 Day 1 Visit • 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 (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial • Known hypersensitivity to the study drugs, the metabolites, or formulation excipients • Previous reaction to contrast media or sensitivity to iodine or a known clinical hypersensitivity including a history of bronchial asthma, hay fever, or food allergies. • Patients receiving ongoing therapy with any drugs not to be used with Stribild, Truvada, Atripla, Kivexa, and ritonavir-boosted atazanavir (Reyataz)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess glomerular function before and during administration of Stribild (STB) or a regimen containing Tenofovir disoproxil fumarate (TDF) without Cobisistat (COBI) as ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate (ATV/r+FTC/TDF) or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) compared to a regimen containing neither TDF nor COBI as ritonavir-boosted atazanavir plus abacavir/lamivudine (ATV/r+ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR) through 24 weeks.;Secondary Objective: To assess tubular function before and during administration of STB, ATV/r+FTC/TDF, or EFV/FTC/TDF compared to a regimen of ATV/r+ABC/3TC. To evaluate the pharamacokinetics (PK), antiviral activity, efficacy, safety, and tolerability of the three treatment regimens through 24 weeks of treatment.;Primary end point(s): • Actual glomerular filtration rate (aGFR) using iohexol at Week 24 • Estimated GFR calculated by Cockcroft-Gault formula at Week 24 • Estimated GFR calculated by Modification of Diet in Renal Disease (MDRD) formula at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Renal biomarkers of tubular function: urine glucose (along with serum glucose), urine albumin to creatinine ratio, urine protein to creatinine ratio, urine ß2-microglubulin to creatinine ratio, and urine RBP to creatinine ratio. • PK parameter assessments for COBI, RTV, TFV and iohexol • The proportion of patients with HIV 1 RNA < 50 copies/mL at Week 24 • The change from baseline in CD4+ cell count at Week 24 • The incidences of adverse events and laboratory abnormalities. ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Belgium, Ireland, Spain, United Kingdom
Contacts
Public ContactClinical Trials Inbox
Gilead Sciences International Ltd
Outcome results
None listed