NCT02246998 - 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 | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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 * 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 Key Exclusion Criteria: * 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 * 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24

Time frame: Week 24

Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) \* (mass in kg) \* (0.85 if female) divided by 72 \* serum creatinine in mg/dL

Time frame: Week 24

Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24

MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m\^2) = 186 \* (Scr)\^-1.154 \* (Age)\^(-0.203) \* (0.742 if female) \* (1.212 if black). Scr = serum creatinine in mg/dL

Time frame: Week 24

Secondary Outcomes

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)

Time frame: Up to 24 weeks plus 30 days

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)

Time frame: Up to 24 weeks plus 30 days

Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24

Time frame: Baseline; Week 24

Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24

Time frame: Baseline; Week 24

Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24

Time frame: Baseline; Week 24

Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24

Time frame: Baseline; Week 24

Pharmacokinetic (PK) Parameter: Cmax for COBI

Cmax is defined as the maximum observed concentration of drug in plasma.