At a glance
ClinicalIndex Comparison Record- ✓Cohort 1: treatment-naive with plasma HIV-1 RNA ≥1,000 copies/mL at screening
- ✓Cohort 1: genotype sensitivity to FTC and TDF
- ✓Cohort 2: on ATV/RTV or DRV/RTV with 2 NRTIs for ≥6 months
- ✓Cohort 2: undetectable viral load for 6 months prior to screening and <50 copies/mL at screening
- ✕AIDS-defining condition within 30 days prior to screening
- ✕Active hepatitis C treatment or anticipated treatment
- ✕Decompensated cirrhosis
- ✕Implanted defibrillator or pacemaker
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating E/C/F/TDF, COBI, and 3 other interventions for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 106 participants across 51 sites in 9 countries.
Detailed Summary
This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.
Study Details
Timeline
Interventions
E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily
COBI 150 mg tablet administered with food orally once daily
ATV 300 mg tablet administered orally once daily
DRV 800 mg tablet administered orally once daily
Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.