Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
NCT ID: NCT02246998
Last Updated: 2018-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2014-12-15
2016-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STB+iohexol
Participants will receive STB+iohexol for 24 weeks.
STB
150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
Iohexol
1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
RTV+ATV+TVD+iohexol
Participants will receive RTV+ATV+TVD+iohexol for 24 weeks.
TVD
200/300 mg FDC tablet administered orally once daily with food
RTV
100 mg tablet administered orally once daily with food
ATV
300 mg capsule administered orally once daily with food
Iohexol
1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
ATR+iohexol
Participants will receive ATR+iohexol for 24 weeks.
ATR
600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
Iohexol
1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
RTV+ATV+ABC/3TC+iohexol
Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.
RTV
100 mg tablet administered orally once daily with food
ATV
300 mg capsule administered orally once daily with food
ABC/3TC
600/300 mg FDC tablet administered orally once daily with food
Iohexol
1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
Interventions
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STB
150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
TVD
200/300 mg FDC tablet administered orally once daily with food
ATR
600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
RTV
100 mg tablet administered orally once daily with food
ATV
300 mg capsule administered orally once daily with food
ABC/3TC
600/300 mg FDC tablet administered orally once daily with food
Iohexol
1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) ≤ 5 × upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL (≤ 26 umol/L), or normal direct bilirubin
* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
* Serum amylase ≤ 5 × ULN (individuals with serum amylase \> 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
* Normal electrocardiogram (ECG) or not clinically significant if abnormal ECG
* Not pregnant or non-lactating females of non-childbearing potential. Or females with childbearing potential who agree 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 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose
* Males who 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 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose. Males who agree to refrain from sperm donation from first dose until at least 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose
* Body mass index (BMI) of 19 ≤ BMI ≤ 30 kg/m\^2 and body weight ≥ 40 kg
* Life expectancy ≥ 1 year
Exclusion Criteria
* 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
* Individuals experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test
* Have an implanted defibrillator or pacemaker
* Current alcohol or substance that could potentially interfere with 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. Individuals 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
18 Years
55 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Brussels, , Belgium
Ghent, , Belgium
Lyon, , France
Paris, , France
Rennes, , France
Tourcoing, , France
Dublin, , Ireland
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
Brighton, , United Kingdom
Bristol, , United Kingdom
Coventry, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2014-002095-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-236-0140
Identifier Type: -
Identifier Source: org_study_id
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