EUCTR2014-002095-93-ES
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
- Human Immunodeficiency Virus, Type 1 (HIV-1) Infection
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 72
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The ability to understand and sign a written informed consent form
- •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
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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