Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
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.
Acquired Immunodeficiency Syndrome
|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|
- Change from baseline in estimated glomerular filtration rate [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
- Proportion of participants achieving virologic response (HIV-1 RNA < 50 copies/mL) [ Time Frame: Weeks 24, 48 and 96 ] [ Designated as safety issue: No ]
- Long term effect of COBI-containing regimens on renal parameters [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: Yes ]Safety data regarding renal parameters will be summarized.
- Incidence of adverse events and graded laboratory abnormalities [ Time Frame: Baseline to Week 96 plus 30 days ] [ Designated as safety issue: No ]All safety data will be summarized by treatment group.
- Plasma pharmacokinetics (PK) parameters of COBI as measured by Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½. [ Time Frame: Baseline, Weeks, 2, 4, and 24 ] [ Designated as safety issue: No ]
- Cmax is defined as the maximum observed concentration of drug in plasma
- Tmax is defined as the time of Cmax
- Clast is defined as the last observable concentration of drug
- Tlast is defined as the time of Clast
- Ctau is defined as the observed drug concentration at the end of the dosing interval
- λz is defined as the terminal elimination rate constant
- AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
- t1/2 is defined as the estimate of the terminal elimination half-life of the drug
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Participants will receive EVG/COBI/FTC/TDF STR for 96 weeks.
Cohort 1: Single tablet regimen of elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg
Other Name: Stribild®
Experimental: ATV/co or DRV/co
Participants will receive ATV/co or DRV/co, plus 2 NRTIs, for 96 weeks.
Cobicistat (COBI, /co) 150 mg tablet administered with food orally once daily
Other Name: Tybost™Drug: ATV
Atazanavir (ATV) 300 mg tablet administered orally once daily
Other Name: Reyataz®Drug: DRV
Darunavir (DRV) 800 mg tablet administered orally once daily
Other Name: Prezista®Drug: NRTI
Participants will receive 2 invesigator-selected nucleoside reverse transcriptase inhibitors (NRTIs), which may include abacavir (ABC), combivir, didanosine (DDI), emtricitabine (FTC), epzicom, lamivudine (3TC), tenofovir disoproxil fumarate (TDF), or truvada (TVD), administered according to prescribing information.
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|Study Director:||Javier Szwarcberg, MD||Gilead Sciences|