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NCT00054717 Clinical Trial

Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

HIV Infections Clinical Trial

Official title:
Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00054717
Other study ID # 1182.12
Secondary ID
Status Completed
Phase Phase 3
First received February 7, 2003
Last updated June 23, 2014
Start date January 2003

Study information
Verified date April 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Responsilble Ethics CommitteeCanada: Health Canada (TPD)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Recruitment information / eligibility
Status Completed
Enrollment 630
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients meeting the following criteria will be eligible for participation in th is study:

1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.

2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:

30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.

3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.

4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

Exclusion criteria:

Patients with any of the following criteria are excluded from participation in t he study:

1. Antiretroviral (ARV) medication naïve.

2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.

3. alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tipranavir

• Ritonavir(r)

• Comparator Protease Inhibitor (CPI)

Locations
Country Name City State
Australia 1182.12.1401 St. Vincent's Hospital Darlinghurst New South Wales
Australia 1182.12.1405 AIDS Research Initiative / Ground Zero Darlinghurst New South Wales
Australia 1182.12.1407 Holdsworth House General Practice Darlinghurst New South Wales
Australia 1182.12.1408 407 Doctors Pty Ltd. Darlinghurst New South Wales
Australia 1182.12.1404 Alfred Hospital Melbourne Victoria
Australia 1182.12.1406 Gold Coast Sexual Health Clinic Miami Queensland
Australia 1182.12.1403 Albion Street Centre Surry Hills New South Wales
Canada 1182.12.11016 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1182.12.11012 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1182.12.11015 Boehringer Ingelheim Investigational Site Monteal Quebec
Canada 1182.12.11003 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1182.12.11007 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1182.12.11013 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1182.12.11001 Boehringer Ingelheim Investigational Site Ottawa Ontario
Canada 1182.12.11004 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1182.12.11006 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1182.12.11009 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1182.12.11014 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1182.12.11002 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Canada 1182.12.11010 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Puerto Rico 1182.12.60 Boehringer Ingelheim Investigational Site Santurce
United States 1182.12.109 Boehringer Ingelheim Investigational Site Akron Ohio
United States 1182.12.68 Boehringer Ingelheim Investigational Site Albany New York
United States 1182.12.13 University of Michigan Health System Ann Arbor Michigan
United States 1182.12.91 Boehringer Ingelheim Investigational Site Annandale Virginia
United States 1182.12.123 Infectious Disease Clinics of Emory Atlanta Georgia
United States 1182.12.88 Boehringer Ingelheim Investigational Site Atlanta Georgia
United States 1182.12.30 Boehringer Ingelheim Investigational Site Baltimore Maryland
United States 1182.12.9 Boehringer Ingelheim Investigational Site Berkeley California
United States 1182.12.6 Boehringer Ingelheim Investigational Site Bethesda Maryland
United States 1182.12.23 Boehringer Ingelheim Investigational Site Beverly Hills California
United States 1182.12.8 Family Practice Medical Center Boise Idaho
United States 1182.12.100 Boehringer Ingelheim Investigational Site Boston Massachusetts
United States 1182.12.101 Boehringer Ingelheim Investigational Site Boston Massachusetts
United States 1182.12.41 Boehringer Ingelheim Investigational Site Boston Massachusetts
United States 1182.12.4 Boehringer Ingelheim Investigational Site Camden New Jersey
United States 1182.12.105 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1182.12.3 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1182.12.49 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1182.12.24 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1182.12.35 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 1182.12.10 Boehringer Ingelheim Investigational Site Columbia South Carolina
United States 1182.12.65 Ohio State University Medical Center Columbus Ohio
United States 1182.12.106 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1182.12.55 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1182.12.72 Boehringer Ingelheim Investigational Site Decatur Georgia
United States 1182.12.98 University of Colorado Health Sciences Center Denver Colorado
United States 1182.12.54 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 1182.12.56 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 1182.12.42 Boehringer Ingelheim Investigational Site Durham North Carolina
United States 1182.12.21 Boehringer Ingelheim Investigational Site East Orange New Jersey
United States 1182.12.79 Boehringer Ingelheim Investigational Site Fort Lauderdale Florida
United States 1182.12.77 Boehringer Ingelheim Investigational Site Fort Myers Florida
United States 1182.12.12 Boehringer Ingelheim Investigational Site Fountain Valley California
United States 1182.12.116 Greenville Hospital System Greenville South Carolina
United States 1182.12.114 Pinnacle Health Harrisburg Pennsylvania
United States 1182.12.31 Boehringer Ingelheim Investigational Site Houston Texas
United States 1182.12.73 Boehringer Ingelheim Investigational Site Houston Texas
United States 1182.12.46 Boehringer Ingelheim Investigational Site Huntersville North Carolina
United States 1182.12.32 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1182.12.48 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1182.12.14 Dybedal Center for Clinical Research Kansas City Missouri
United States 1182.12.11 Wellness Center Las Vegas Nevada
United States 1182.12.33 Boehringer Ingelheim Investigational Site Lexington Kentucky
United States 1182.12.76 Boehringer Ingelheim Investigational Site Long Beach California
United States 1182.12.1 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1182.12.59 David Geffen School of Medicine at UCLA Los Angeles California
United States 1182.12.82 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1182.12.97 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1182.12.44 Boehringer Ingelheim Investigational Site Louisville Kentucky
United States 1182.12.47 Boehringer Ingelheim Investigational Site Macon Georgia
United States 1182.12.2 Boehringer Ingelheim Investigational Site Memphis Tennessee
United States 1182.12.45 Boehringer Ingelheim Investigational Site Miami Florida
United States 1182.12.75 CARES Resource Miami Florida
United States 1182.12.85 Boehringer Ingelheim Investigational Site Miami Florida
United States 1182.12.93 Boehringer Ingelheim Investigational Site Miami Beach Florida
United States 1182.12.29 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin
United States 1182.12.120 Department of Medicine, HIV/AIDS Program Minneapolis Minnesota
United States 1182.12.34 Boehringer Ingelheim Investigational Site Mount Vernon New York
United States 1182.12.95 Boehringer Ingelheim Investigational Site New Orleans Louisiana
United States 1182.12.119 Boehringer Ingelheim Investigational Site New York New York
United States 1182.12.22 Boehringer Ingelheim Investigational Site New York New York
United States 1182.12.36 Boehringer Ingelheim Investigational Site New York New York
United States 1182.12.58 Beth Israel Medical Center New York New York
United States 1182.12.96 Boehringer Ingelheim Investigational Site New York New York
United States 1182.12.7 Boehringer Ingelheim Investigational Site Norwalk Connecticut
United States 1182.12.80 Infectious Disease Institute Clinical Trials Unit Oklahoma City Oklahoma
United States 1182.12.17 Boehringer Ingelheim Investigational Site Orlando Florida
United States 1182.12.28 University of Pennsylvania Philadelphia Pennsylvania
United States 1182.12.50 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania
United States 1182.12.62 Boehringer Ingelheim Investigational Site Phoenix Arizona
United States 1182.12.81 Boehringer Ingelheim Investigational Site Portland Maine
United States 1182.12.86 The Miriam Hospital Providence Rhode Island
United States 1182.12.122 VCU Health Systems Richmond Virginia
United States 1182.12.107 Boehringer Ingelheim Investigational Site Rochester New York
United States 1182.12.69 UC Davis Medical Center Sacramento California
United States 1182.12.26 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1182.12.89 Boehringer Ingelheim Investigational Site San Diego California
United States 1182.12.99 Boehringer Ingelheim Investigational Site San Diego California
United States 1182.12.25 Boehringer Ingelheim Investigational Site San Francisco California
United States 1182.12.5 Boehringer Ingelheim Investigational Site San Francisco California
United States 1182.12.53 Boehringer Ingelheim Investigational Site San Francisco California
United States 1182.12.40 Boehringer Ingelheim Investigational Site Santa Fe New Mexico
United States 1182.12.90 Boehringer Ingelheim Investigational Site Sarasota Florida
United States 1182.12.15 Boehringer Ingelheim Investigational Site Seattle Washington
United States 1182.12.61 Boehringer Ingelheim Investigational Site Springfield Massachusetts
United States 1182.12.87 Boehringer Ingelheim Investigational Site St Louis Missouri
United States 1182.12.83 Boehringer Ingelheim Investigational Site Stony Brook New York
United States 1182.12.63 Boehringer Ingelheim Investigational Site Tampa Florida
United States 1182.12.78 Boehringer Ingelheim Investigational Site Tampa Florida
United States 1182.12.94 Infectious Disease Research Institute Tampa Florida
United States 1182.12.108 El Rio SIA Tucson Arizona
United States 1182.12.43 Boehringer Ingelheim Investigational Site Valhalla New York
United States 1182.12.67 Boehringer Ingelheim Investigational Site Vero Beach Florida
United States 1182.12.103 Boehringer Ingelheim Investigational Site Washington District of Columbia
United States 1182.12.52 Boehringer Ingelheim Investigational Site Washington District of Columbia
United States 1182.12.70 Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment Response at Week 48 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound At week 48 No
Primary Time to Treatment Failure Through 48 Weeks of Treatment Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline. Week 48 No
Secondary Treatment Response at Week 24 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 24 No
Secondary Treatment Response at Week 2 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 2 No
Secondary Treatment Response at Week 4 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 4 No
Secondary Treatment Response at Week 8 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 8 No
Secondary Treatment Response at Week 16 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 16 No
Secondary Treatment Response at Week 32 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 32 No
Secondary Treatment Response at Week 40 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 40 No
Secondary Treatment Response at Week 48 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 48 No
Secondary Treatment Response at Week 56 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 56 No
Secondary Treatment Response at Week 64 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound week 64 No
Secondary Treatment Response at Week 72 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 72 No
Secondary Treatment Response at Week 80 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 80 No
Secondary Treatment Response at Week 88 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 88 No
Secondary Treatment Response at Week 96 Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound Week 96 No
Secondary Time to Treatment Failure Through 96 Weeks of Treatment time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline. Week 96 No
Secondary Time to Confirmed Virologic Failure Through 48 Weeks of Treatment Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log. Week 48 No
Secondary Time to Confirmed Virologic Failure Through 96 Weeks of Treatment Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log. Week 96 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 2 through Week 96 (at any point during trial) No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 2 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 2 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 4 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 4 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 8 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 8 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 16 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 16 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 24 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 24 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 32 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 32 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 40 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 40 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 48 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 48 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 56 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 56 No
Secondary Virologic Response (Viral Load >= 1 Log Drop) at Week 64 Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline Week 64 No
Secondary Median Change From Baseline in Viral Load to Week 2 Baseline to Week 2 No
Secondary Median Change From Baseline in Viral Load to Week 4 Baseline to Week 4 No
Secondary Median Change From Baseline in Viral Load to Week 8 Baseline to Week 8 No
Secondary Median Change From Baseline in Viral Load to Week 16 Baseline to Week 16 No
Secondary Median Change From Baseline in Viral Load to Week 24 Baseline to Week 24 No
Secondary Median Change From Baseline in Viral Load to Week 32 Baseline to Week 32 No
Secondary Median Change From Baseline in Viral Load to Week 40 Baseline to Week 40 No
Secondary Median Change From Baseline in Viral Load to Week 48 Baseline to Week 48 No
Secondary Median Change From Baseline in Viral Load to Week 56 Baseline to Week 56 No
Secondary Median Change From Baseline in Viral Load to Week 64 Baseline to Week 64 No
Secondary Median Change From Baseline in Viral Load to Week 72 Baseline to Week 72 No
Secondary Median Change From Baseline in Viral Load to Week 80 Baseline to Week 80 No
Secondary Median Change From Baseline in Viral Load to Week 88 Baseline to Week 88 No
Secondary Median Change From Baseline in Viral Load to Week 96 Baseline to Week 96 No
Secondary Mean Change From Baseline to Week 2 in CD4+ Cell Count Baseline to Week 2 No
Secondary Mean Change From Baseline to Week 4 in CD4+ Cell Count Baseline to Week 4 No
Secondary Mean Change From Baseline to Week 8 in CD4+ Cell Count Baseline to Week 8 No
Secondary Mean Change From Baseline to Week 16 in CD4+ Cell Count Baseline to Week 16 No
Secondary Mean Change From Baseline to Week 24 in CD4+ Cell Count Baseline to Week 24 No
Secondary Mean Change From Baseline to Week 32 in CD4+ Cell Count Baseline to Week 32 No
Secondary Mean Change From Baseline to Week 40 in CD4+ Cell Count Baseline to Week 40 No
Secondary Mean Change From Baseline to Week 48 in CD4+ Cell Count Baseline to Week 48 No
Secondary Mean Change From Baseline to Week 56 in CD4+ Cell Count Baseline to Week 56 No
Secondary Mean Change From Baseline to Week 64 in CD4+ Cell Count Baseline to Week 64 No
Secondary Mean Change From Baseline to Week 72 in CD4+ Cell Count Baseline to Week 72 No
Secondary Mean Change From Baseline to Week 80 in CD4+ Cell Count Baseline to Week 80 No
Secondary Mean Change From Baseline to Week 88 in CD4+ Cell Count Baseline to Week 88 No
Secondary Mean Change From Baseline to Week 96 in CD4+ Cell Count Baseline to Week 96 No
Secondary Time to New CDC Class C Progression Event or Death. Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death after 48 weeks of treatment No
Secondary Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF Percentage of participants with Viral Load < 400 copies/mL Week 2 through Week 96 (at any point during trial) No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 2 Percentage of participants with Viral Load < 400 copies/mL Week 2 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 4 Percentage of participants with Viral Load < 400 copies/mL Week 4 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 8 Percentage of participants with Viral Load < 400 copies/mL Week 8 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 16 Percentage of participants with Viral Load < 400 copies/mL Week 16 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 24 Percentage of participants with Viral Load < 400 copies/mL Week 24 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 32 Percentage of participants with Viral Load < 400 copies/mL week 32 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 40 Percentage of participants with Viral Load < 400 copies/mL Week 40 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 48 Percentage of participants with Viral Load < 400 copies/mL Week 48 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 56 Percentage of participants with Viral Load < 400 copies/mL Week 56 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 64 Percentage of participants with Viral Load < 400 copies/mL Week 64 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 72 Percentage of participants with Viral Load < 400 copies/mL Week 72 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 80 Percentage of participants with Viral Load < 400 copies/mL Week 80 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 88 Percentage of participants with Viral Load < 400 copies/mL week 88 No
Secondary Virologic Response (VL < 400 Copies/ml) at Week 96 Percentage of participants with Viral Load < 400 copies/mL week 96 No
Secondary Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF Percentage of participants with Viral Load < 50 copies/mL Week 2 through Week 96 (at any point during trial) No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 2 Percentage of participants with Viral Load < 50 copies/mL Week 2 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 4 Percentage of participants with Viral Load < 50 copies/mL Week 4 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 8 Percentage of participants with Viral Load < 50 copies/mL Week 8 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 16 Percentage of participants with Viral Load < 50 copies/mL Week 16 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 24 Percentage of participants with Viral Load < 50 copies/mL Week 24 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 32 Percentage of participants with Viral Load < 50 copies/mL Week 32 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 40 Percentage of participants with Viral Load < 50 copies/mL Week 40 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 48 Percentage of participants with Viral Load < 50 copies/mL Week 48 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 56 Percentage of participants with Viral Load < 50 copies/mL Week 56 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 64 Percentage of participants with Viral Load < 50 copies/mL Week 64 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 72 Percentage of participants with Viral Load < 50 copies/mL Week 72 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 80 Percentage of participants with Viral Load < 50 copies/mL Week 80 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 88 Percentage of participants with Viral Load < 50 copies/mL Week 88 No
Secondary Virologic Response (VL < 50 Copies/ml) at Week 96 Percentage of participants with Viral Load < 50 copies/mL Week 96 No
Secondary Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. 240 Weeks No
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