Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
HIV
Interventions
DRUG

Atazanavir

Capsule, Oral, 300 mg, Once daily (QD), 48 weeks

DRUG

Darunavir

Oral, Two 400 mg Tablets, Once daily (QD), 48 weeks

DRUG

Ritonavir

Tablet, Oral, 100 mg, Once daily (QD), 48 weeks

DRUG

Optimized NRTI backbone

"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"

Trial Locations (14)

10468

James J Peters VAMC, The Bronx

46202

Indiana University Hospital, Indianapolis

63139

Southampton Health Center, St Louis

72207

Health For Life Clinic Pllc, Little Rock

85006

Southwest Center For Hiv/Aids, Phoenix

90069

Anthony M. Mills Md Inc, Los Angeles

94109

Metropolis Medical Pc, San Francisco

95817

Uc Davis Medical Center, Sacramento

Unknown

Southwest Center For Hiv/Aids, Phoenix

Be Well Medical Center, Berkley

Southampton Health Center, St Louis

Infectious Disease Clinic & AI, The Bronx

08844

I.D. Care Associates, Hillsborough

07102

Saint Michael'S Medical Center, Newark

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY