A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

Phase 3

Completed

• Conditions: Human Immunodeficiency virus (HIV-1) infections; renal impairment; 10047438; 10038430

• Registration Number: NL-OMON41597
• Lead Sponsor: Gilead Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* CD4+ count of >50 cells/*L
* Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening). Measurements difference versus screening value must be <25% of the screening value
* Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline
* Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
* Hepatic transaminases (AST and ALT) * 5 x upper limit of normal (ULN)
* Total bilirubin * 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert*s Syndrome or hyperbilirubinemia due to atazanavir therapy may have total bilirubin up to 5 x ULN).
* Adequate hematologic function (absolute neutrophil count * 1,000/mm3; platelets * 50,000/mm3; hemoglobin * 8.5 g/dL)
* Serum amylase * 5 x ULN (subjects with serum amylase > 5 x ULN will remain eligible if serum lipase is * 5 x ULN)
* Females of childbearing potential (as defined in Section *7.8) must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
* Female subjects 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 subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or male subjects must be non-heterosexually active, or practice sexual abstinence.
* Age * 18 years

Exclusion Criteria

* A new AIDS defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening,with the exception of the first two bullet points (refer to Appendix 6)
* HCV antibody positive. Subjects who are HCV positive, but have a documented negative
HCV RNA, are eligible
* Hepatitis B surface antigen (HBVsAg) positive
* Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
* Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
* Females who are breastfeeding
* Positive serum pregnancy test (female 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. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline 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 Baseline
* Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
* Subjects receiving ongoing therapy with any of the medications in the table below, including drugs not to be used with EVG, COBI, FTC, or TAF (refer to the individual agents Prescribing Information); or subjects with any known allergies to the excipients of E/C/F/TAF STR

Study & Design

• Study Type: Interventional
• Study Design: Not specified