Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01363011
First received: May 11, 2011
Last updated: October 10, 2012
Last verified: October 2012
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The purpose of this study is to characterize the effect of Cobicistat based regimens on parameters of renal function in HIV infected patients with mild to moderate renal impairment, and also, to assess the safety and tolerability of those regimens in order to generate appropriate dosing recommendations.
Condition | Intervention | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome HIV Infections |
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir DF Drug: cobicistat and atazanavir or cobicistat and darunavir |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Atazanavir
Tenofovir Disoproxil Fumarate
Darunavir
Atazanavir sulfate
Darunavir ethanolate
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- primary endpoint is the change from baseline to Week 24 in estimated creatinine clearance [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The proportion of subjects achieving virologic response at Weeks 24 and 48 (HIV-1 RNA < 50 copies/mL) [ Time Frame: 24 & 48 Weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: | 100 |
Study Start Date: | May 2011 |
Estimated Study Completion Date: | March 2014 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir DF
Single tablet regimen (STR) of elvitegravir (EVG) 150mg/ cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (EVG/COBI/FTC/TDF)
|
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir DF
Cohort 1: Single tablet regimen of elvitegravir 150mg/ cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (n = at least 33 subjects)
|
Experimental: cobicistat and atazanavir or cobicistat and darunavir
cobicistat boosted atazanavir + 2 NRTIs OR cobicistat boosted darunavir + 2 NRTIs
|
Drug: cobicistat and atazanavir or cobicistat and darunavir
Cohort 2: cobicistat boosted atazanavir + 2 NRTIs or cobicistat boosted darunavir + 2 NRTIs
|
![](https://webarchive.library.unt.edu/web/20130312001020im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Cohort 1 (Treatment Naïve)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report must show sensitivity to FTC and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of time
Cohort 2 (Pharmacoenhancer Switch)
- Subjects must be receiving ATV 300 mg/RTV 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening
- Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
- Subjects experiencing intolerance to RTV (as determined by the Investigator)
Cohort 1 and Cohort 2
- The ability to understand and sign a written informed consent form
- Normal ECG
- Mild to Moderate renal function
- Stable renal function
- Hepatic transaminases (AST and ALT) ≤ 5 x 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 upper limit of normal)
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
- Age ≥ 18 years
Exclusion Criteria:
- New AIDS defining condition diagnosed within the 30 days prior to screening
- Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
- Subjects experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
- Receiving ongoing therapy with any of medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, COBI tablets, atazanavir capsules or darunavir tablets or contraindicated for the 2 NRTIs as part of the Cohort 2 regimen
- Participation in any other clinical trial without prior approval
- Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01363011
Show 53 Study Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: | Andrew Cheng, MD, PhD | Gilead Sciences |
![](https://webarchive.library.unt.edu/web/20130312001020im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01363011 History of Changes |
Other Study ID Numbers: | GS-US-236-0118 |
Study First Received: | May 11, 2011 |
Last Updated: | October 10, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
HIV-1 Treatment Naive Treatment Experienced |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Tenofovir Tenofovir disoproxil Atazanavir |
Darunavir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on March 10, 2013