Overview
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
Status:
Completed
Completed
Trial end date:
2016-02-17
2016-02-17
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (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).Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gilead SciencesTreatments:
Abacavir
Atazanavir Sulfate
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine
Ritonavir
Tenofovir
Criteria
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.