The purpose of this study is to determine the proportion of subjects with HIV-1 RNA \< 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor
Allocation: Randomization will be stratified * ATV = Atazanavir * DRV = Darunavir * RTV = Ritonavir
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Capsule, Oral, 300 mg, Once daily (QD), 48 weeks
Oral, Two 400 mg Tablets, Once daily (QD), 48 weeks
Tablet, Oral, 100 mg, Once daily (QD), 48 weeks
Southwest Center For Hiv/Aids
Phoenix, Arizona, United States
Southwest Center For Hiv/Aids
Phoenix, Arizona, United States
Health For Life Clinic Pllc
Little Rock, Arkansas, United States
Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
Time frame: At Week 48
Proportion of subjects with HIV-1 RNA < 50 c/mL
Time frame: At week 24
Change from baseline in CD4 cell count
Time frame: Baseline (Week 0) and at week 48
Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation
Time frame: up to week 48
Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure
Time frame: up to week 48
Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence
Time frame: Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tablet/capsule, Noninvestigational products i.e. NRTI backbone will be administered according to their respective package inserts for 48 weeks NRTI backbone are: \- Abacavir (300 mg), Tenofovir (300 mg), Didanosine (250 mg or 400 mg), Stavudine (30 mg or 40 mg), Emtricitabine (200 mg), Lamivudine (300 mg), Zidovudine (300 mg), EPZICOM® (600 mg Ziagen® + 300 mg Lamivudine), COMBIVIR® (150 mg Lamivudine + 300 mg Zidovudine) The following NRTI combinations are prohibited in this study: * Didanosine + Stavudine * Zidovudine + Stavudine * Lamivudine + Emtricitabine
Anthony M. Mills Md Inc
Los Angeles, California, United States
Uc Davis Medical Center
Sacramento, California, United States
Metropolis Medical Pc
San Francisco, California, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Be Well Medical Center
Berkley, Michigan, United States
Southampton Health Center
St Louis, Missouri, United States
Southampton Health Center
St Louis, Missouri, United States
...and 4 more locations