EUCTR2014-002095-93-GB
Active, not recruiting
Phase 1
A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF or Efavirenz /Emtricitabine/Tenofovir DF) compared to Ritonavir boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR =70 mL/min
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The ability to understand and sign a written informed consent form (ICF)
- •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 according to the Cockcroft Gault formula for creatinine clearance (CLcr)
- •Hepatic transaminases (AST and ALT) \= 5 × upper limit of normal (ULN)
- •Total bilirubin \= 1\.5 mg/dL (\<\=26umol/L), or normal direct bilirubin
- •Adequate hematologic function
- •Serum amylase \= 5 × ULN (patients with serum amylase \> 5 × ULN will remain eligible if serum lipase is \= 5 × ULN)
Exclusion Criteria
- •Patients who are 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
- •Patients experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- •Females who are breastfeeding
- •Positive serum pregnancy test (females 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. Patients 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
Outcomes
Primary Outcomes
Not specified
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