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
Launched by GILEAD SCIENCES · Sep 19, 2014
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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.
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Madrid, , Spain
Bristol, , United Kingdom
London, , United Kingdom
Brussels, , Belgium
Manchester, , United Kingdom
Dublin, , Ireland
Paris, , France
Brighton, , United Kingdom
Lyon, , France
Rennes, , France
Liverpool, , United Kingdom
Birmingham, , United Kingdom
Tourcoing, , France
Sheffield, , United Kingdom
Ghent, , Belgium
Newcastle, , United Kingdom
Coventry, , United Kingdom
Bournemouth, , United Kingdom
Seville, , Spain
Patients applied
Trial Officials
Gilead Study Director
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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