Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

HIV Infections Clinical Trial

Official title:

Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144170
• Other study ID #: 1182.48
• Secondary ID: RESIST 2
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: June 23, 2014
• Start date: February 2003

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaAustria: Bundesministerium fuer soziale Sicherheit und GenerationenBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and MedicaGreece: National Organization of MedicinesIreland: Irish Medicines BoardItaly: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - MilanoMexico: Federal Commission for Protection Against Health RisksNetherlands: Central Committee Research Involving Human SubjectsPortugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 LisboaSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent prior to trial participation.

2. Human immunodeficiency virus-1 infected males or females >=18 years of age.

3. Screening genotypic resistance report indicating both of the following:

• at least one primary protease 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.

4. At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,

• with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and

• current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.

5. Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.

6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:

• Total cholesterol <=400 mg/dl or 10,36 mm/L.

• Total triglycerides <=750 mg/dl or 8,5 mm/L.

• Alanine aminotransferase <=3x upper limit of normal and aspartate aminotransferase <=2.5x upper limit of normal.

• Any Grade gamma-glutamyl transpeptidase is acceptable.

• Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.

• All other laboratory test values <= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).

7. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.

8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.

9. A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).

Exclusion Criteria:

1. Antiretroviral medication naïve.

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

3. Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.

4. Female patients of child-bearing potential who:

• have a positive serum pregnancy test at screening or during the study,

• are breast feeding

• are planning to become pregnant, or

• are not willing to use a barrier method of contraception, or

• require ethinyl estradiol administration

5. Prior tipranavir use.

6. Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)

7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).

8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.

9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tipranavir (with low dose ritonavir)

• Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Locations

Country	Name	City	State
Argentina	1182.48.5401 Fundación Huésped	Buenos Aires
Argentina	1182.48.5402 Fundación Huésped	Buenos Aires
Argentina	1182.48.5403 Servicio de Infecciosas	Buenos Aires
Argentina	1182.48.5404 Servicio de Infecciosas	Buenos Aires
Argentina	1182.48.5405 Hospital Muniz	Buenos Aires
Argentina	1182.48.5406 Servicio de Immunocomprometido	Buenos Aires
Austria	1182.48.4301 Boehringer Ingelheim Investigational Site	Wien
Belgium	1182.48.3209 Boehringer Ingelheim Investigational Site	Antwerpen
Belgium	1182.48.3201 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1182.48.3202 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1182.48.3206 Boehringer Ingelheim Investigational Site	Charleroi
Belgium	1182.48.3207 Boehringer Ingelheim Investigational Site	Gent
Belgium	1182.48.3210 Boehringer Ingelheim Investigational Site	Luxembourg
Brazil	1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM	Campinas - SP
Brazil	1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC	Curitiba - PR
Brazil	1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde	Nova Iguaçu - RJ
Brazil	1182.48.5502 Fundação Oswaldo Cruz	Rio de Janeiro - RJ
Brazil	1182.48.5509 Universidade Federal do Rio de Janeiro	Rio de Janeiro - RJ
Brazil	1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d	Salvador - BA
Brazil	1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia	São Paulo - SP
Brazil	1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas	São Paulo - SP
Brazil	1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE	São Paulo - SP
Brazil	1182.48.5506 Centro de Referência e Treinamento - DST/AIDS	São Paulo - SP
Brazil	1182.48.5508 I.I. Emilio Ribas	São Paulo - SP
Brazil	1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo	São Paulo - SP
Brazil	1182.48.5513 UNIFESP - Centro de Pesquisa Clinica	São Paulo - SP
Denmark	1182.48.4505 Boehringer Ingelheim Investigational Site	Aarhus N
Denmark	1182.48.4502 Boehringer Ingelheim Investigational Site	Hvidovre
Denmark	1182.48.4501 Boehringer Ingelheim Investigational Site	København Ø
Denmark	1182.48.4504 Boehringer Ingelheim Investigational Site	Odense C
France	1182.48.3311 Boehringer Ingelheim Investigational Site	Besancon cedex
France	1182.48.3317 Boehringer Ingelheim Investigational Site	Bordeaux
France	1182.48.3307 Boehringer Ingelheim Investigational Site	Bordeaux cedex
France	1182.48.3302 Boehringer Ingelheim Investigational Site	Caen
France	1182.48.3303 Boehringer Ingelheim Investigational Site	Clamart
France	1182.48.3305 Boehringer Ingelheim Investigational Site	Le Kremlin Bicetre
France	1182.48.3304 Boehringer Ingelheim Investigational Site	Lyon cedex 02
France	1182.48.3322 Boehringer Ingelheim Investigational Site	Lyon cedex 3
France	1182.48.3308 Boehringer Ingelheim Investigational Site	Marseille cedex 5
France	1182.48.3309 Boehringer Ingelheim Investigational Site	Marseille cedex 9
France	1182.48.3318 Boehringer Ingelheim Investigational Site	Nantes
France	1182.48.3306 Boehringer Ingelheim Investigational Site	Nice cedex 3
France	1182.48.3310 Boehringer Ingelheim Investigational Site	Paris
France	1182.48.3312 Boehringer Ingelheim Investigational Site	Paris
France	1182.48.3321 Boehringer Ingelheim Investigational Site	Paris
France	1182.48.3316 Boehringer Ingelheim Investigational Site	Paris cedex 10
France	1182.48.3323 Boehringer Ingelheim Investigational Site	Paris cedex 14
France	1182.48.3301 Boehringer Ingelheim Investigational Site	Paris cedex 18
France	1182.48.3319 Boehringer Ingelheim Investigational Site	Paris cedex 20
France	1182.48.3315 Boehringer Ingelheim Investigational Site	Rennes
France	1182.48.3313 Boehringer Ingelheim Investigational Site	Strasbourg
France	1182.48.3314 Boehringer Ingelheim Investigational Site	Vandoeuvre les nancy
France	1182.48.3320 Boehringer Ingelheim Investigational Site	Villejuif
Germany	1182.48.4911 Boehringer Ingelheim Investigational Site	Aachen
Germany	1182.48.4901 Boehringer Ingelheim Investigational Site	Berlin
Germany	1182.48.4902 Boehringer Ingelheim Investigational Site	Berlin
Germany	1182.48.4903 Boehringer Ingelheim Investigational Site	Bochum
Germany	1182.48.4918 Boehringer Ingelheim Investigational Site	Bonn
Germany	1182.48.4906 Boehringer Ingelheim Investigational Site	Dortmund
Germany	1182.48.4912 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1182.48.4914 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1182.48.4908 Boehringer Ingelheim Investigational Site	Erlangen
Germany	1182.48.4904 Boehringer Ingelheim Investigational Site	Essen
Germany	1182.48.4924 Boehringer Ingelheim Investigational Site	Frankfurt/Main
Germany	1182.48.4928 Boehringer Ingelheim Investigational Site	Freiburg
Germany	1182.48.4930 Boehringer Ingelheim Investigational Site	Freiburg/Breisgau
Germany	1182.48.4916 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1182.48.4929 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1182.48.4931 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1182.48.4913 Boehringer Ingelheim Investigational Site	Hannover
Germany	1182.48.4920 Boehringer Ingelheim Investigational Site	Hannover
Germany	1182.48.4909 Boehringer Ingelheim Investigational Site	Heidelberg
Germany	1182.48.4905 Boehringer Ingelheim Investigational Site	Köln
Germany	1182.48.4926 Boehringer Ingelheim Investigational Site	Köln
Germany	1182.48.4923 Boehringer Ingelheim Investigational Site	Mannheim
Germany	1182.48.4907 Boehringer Ingelheim Investigational Site	München
Germany	1182.48.4910 Boehringer Ingelheim Investigational Site	München
Germany	1182.48.4915 Boehringer Ingelheim Investigational Site	Osnabrück
Germany	1182.48.4919 Boehringer Ingelheim Investigational Site	Regensburg
Germany	1182.48.4921 Boehringer Ingelheim Investigational Site	Stuttgart
Germany	1182.48.4927 Boehringer Ingelheim Investigational Site	Stuttgart
Greece	1182.48.3001 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3002 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3003 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3004 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3006 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3007 Boehringer Ingelheim Investigational Site	Athens
Greece	1182.48.3005 Boehringer Ingelheim Investigational Site	Goudi, Athens
Greece	1182.48.3010 Boehringer Ingelheim Investigational Site	Patras
Greece	1182.48.3008 Boehringer Ingelheim Investigational Site	Peraeus
Greece	1182.48.3009 Boehringer Ingelheim Investigational Site	Thessaloniki
Ireland	1182.48.3531 Boehringer Ingelheim Investigational Site	Dublin 8
Italy	1182.48.3930 Boehringer Ingelheim Investigational Site	Ancona
Italy	1182.48.3920 Boehringer Ingelheim Investigational Site	Antella (fi)
Italy	1182.48.3926 Boehringer Ingelheim Investigational Site	Bari
Italy	1182.48.3932 Boehringer Ingelheim Investigational Site	Bergamo
Italy	1182.48.3908 Boehringer Ingelheim Investigational Site	Brescia
Italy	1182.48.3929 Boehringer Ingelheim Investigational Site	Busto Arsizio (va)
Italy	1182.48.3917 Boehringer Ingelheim Investigational Site	Ferrara
Italy	1182.48.3919 Boehringer Ingelheim Investigational Site	Firenze
Italy	1182.48.3905 Boehringer Ingelheim Investigational Site	Genova
Italy	1182.48.3927 Boehringer Ingelheim Investigational Site	Genova
Italy	1182.48.3925 Boehringer Ingelheim Investigational Site	Lecco
Italy	1182.48.3910 Boehringer Ingelheim Investigational Site	Macerata
Italy	1182.48.3901 Boehringer Ingelheim Investigational Site	Milano
Italy	1182.48.3907 Boehringer Ingelheim Investigational Site	Milano
Italy	1182.48.3924 Boehringer Ingelheim Investigational Site	Milano
Italy	1182.48.3934 Boehringer Ingelheim Investigational Site	Milano
Italy	1182.48.3915 Boehringer Ingelheim Investigational Site	Modena
Italy	1182.48.3912 Boehringer Ingelheim Investigational Site	Napoli
Italy	1182.48.3921 Boehringer Ingelheim Investigational Site	Padova
Italy	1182.48.3916 Boehringer Ingelheim Investigational Site	Pavia
Italy	1182.48.3922 Boehringer Ingelheim Investigational Site	Pavia
Italy	1182.48.3904 Boehringer Ingelheim Investigational Site	Rimini
Italy	1182.48.3902 Boehringer Ingelheim Investigational Site	Roma
Italy	1182.48.3903 Boehringer Ingelheim Investigational Site	Roma
Italy	1182.48.3909 Boehringer Ingelheim Investigational Site	Roma
Italy	1182.48.3935 Boehringer Ingelheim Investigational Site	Roma
Italy	1182.48.3906 Boehringer Ingelheim Investigational Site	Torino
Italy	1182.48.3914 Boehringer Ingelheim Investigational Site	Torino
Italy	1182.48.3931 Boehringer Ingelheim Investigational Site	Torino
Italy	1182.48.3933 Boehringer Ingelheim Investigational Site	Treviso
Mexico	1182.48.5202 Hospital Lopez Mateos	Mexico
Mexico	1182.48.5203 Centro Guadalajara, Jal.	Mexico
Mexico	1182.48.5201 Centro Médico La Raza IMSS	Mexico, D.F.
Mexico	1182.48.5206 Centro Medico San Vicente	Monterrey, N.l.
Netherlands	1182.48.3101 Boehringer Ingelheim Investigational Site	Amsterdam
Netherlands	1182.48.3106 Boehringer Ingelheim Investigational Site	Amsterdam
Netherlands	1182.48.3110 Boehringer Ingelheim Investigational Site	Den Haag
Netherlands	1182.48.3108 Boehringer Ingelheim Investigational Site	Groningen
Netherlands	1182.48.3105 Boehringer Ingelheim Investigational Site	Nijmegen
Netherlands	1182.48.3104 Boehringer Ingelheim Investigational Site	Rotterdam
Portugal	1182.48.3502 Boehringer Ingelheim Investigational Site	Cascais
Portugal	1182.48.3503 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1182.48.3501 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1182.48.3505 Hospital Egas Moniz	Lisboa
Portugal	1182.48.3504 Hospital de São João	Porto
Spain	1182.48.3415 Boehringer Ingelheim Investigational Site	Alicante
Spain	1182.48.3405 Boehringer Ingelheim Investigational Site	Badalona
Spain	1182.48.3401 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1182.48.3407 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1182.48.3408 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1182.48.3409 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1182.48.3406 Boehringer Ingelheim Investigational Site	L'Hospitalet de Llobregat
Spain	1182.48.3402 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3403 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3404 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3410 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3411 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3412 Boehringer Ingelheim Investigational Site	Madrid
Spain	1182.48.3417 Boehringer Ingelheim Investigational Site	Malaga
Spain	1182.48.3416 Boehringer Ingelheim Investigational Site	San Sebastian
Spain	1182.48.3413 Boehringer Ingelheim Investigational Site	Sevilla
Spain	1182.48.3414 Boehringer Ingelheim Investigational Site	Valencia
Spain	1182.48.3420 Boehringer Ingelheim Investigational Site	Valencia
Spain	1182.48.3418 Boehringer Ingelheim Investigational Site	Vigo
Sweden	1182.48.4603 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	1182.48.4602 Boehringer Ingelheim Investigational Site	Malmö
Sweden	1182.48.4601 Boehringer Ingelheim Investigational Site	Stockholm
Switzerland	1182.48.4101 Universitätsspital Basel	Basel
Switzerland	1182.48.4104 Hopital Universitaire de Genève	Genève
Switzerland	1182.48.4103 Kantonsspital St. Gallen	St. Gallen
Switzerland	1182.48.4102 Universitätsspital Zürich	Zürich
United Kingdom	1182.48.4405 Boehringer Ingelheim Investigational Site	Brighton
United Kingdom	1182.48.4412 Boehringer Ingelheim Investigational Site	Edinburgh
United Kingdom	1182.48.4411 Boehringer Ingelheim Investigational Site	Liverpool
United Kingdom	1182.48.4404 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4406 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4408 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4409 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4414 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4418 Boehringer Ingelheim Investigational Site	London
United Kingdom	1182.48.4417 Boehringer Ingelheim Investigational Site	Newcastle upon Tyne
United Kingdom	1182.48.4407 Boehringer Ingelheim Investigational Site	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Mexico,  Netherlands,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Response at Week 48	Patients who experienced treatment response. 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	after 48 weeks of treatment	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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.	after 48 weeks of treatment	No
Secondary	Treatment Response at Week 2	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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 24	Patients who experienced treatment response. 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 32	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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 56	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	Patients who experienced treatment response. 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	after 96 weeks of treatment	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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.	after 96 weeks of treatment	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 where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.	after 48 weeks of treatment	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 where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.	after 96 weeks of treatment	No
Secondary	Virologic Response	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 2 through Week 96 (at any point during trial)	No
Secondary	Virologic Response at Week 2	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 2	No
Secondary	Virologic Response at Week 4	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 4	No
Secondary	Virologic Response at Week 8	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 8	No
Secondary	Virologic Response at Week 16	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 16	No
Secondary	Virologic Response at Week 24	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 24	No
Secondary	Virologic Response at Week 32	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 32	No
Secondary	Virologic Response at Week 40	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 40	No
Secondary	Virologic Response at Week 48	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 48	No
Secondary	Virologic Response at Week 56	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 56	No
Secondary	Virologic Response at Week 64	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	week 64	No
Secondary	Virologic Response at Week 72	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 72	No
Secondary	Virologic Response at Week 80	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 80	No
Secondary	Virologic Response at Week 88	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 88	No
Secondary	Virologic Response at Week 96	Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1	Week 96	No
Secondary	Median Change From Baseline in Viral Load (Week 2)		Baseline to Week 2	No
Secondary	Median Change From Baseline in Viral Load (Week 4)		Baseline to Week 4	No
Secondary	Median Change From Baseline in Viral Load (Week 8)		Baseline to Week 8	No
Secondary	Median Change From Baseline in Viral Load (Week 16)		Baseline to Week 16	No
Secondary	Median Change From Baseline in Viral Load (Week 24)		Baseline to Week 24	No
Secondary	Median Change From Baseline in Viral Load (Week 32)		Baseline to Week 32	No
Secondary	Median Change From Baseline in Viral Load (Week 40)		Baseline to Week 40	No
Secondary	Median Change From Baseline in Viral Load (Week 48)		Baseline to Week 48	No
Secondary	Median Change From Baseline in Viral Load (Week 56)		Baseline to Week 56	No
Secondary	Median Change From Baseline in Viral Load (Week 64)		Baseline to Week 64	No
Secondary	Median Change From Baseline in Viral Load (Week 72)		Baseline to Week 72	No
Secondary	Median Change From Baseline in Viral Load (Week 80)		Baseline to Week 80	No
Secondary	Median Change From Baseline in Viral Load (Week 88)		Baseline to Week 88	No
Secondary	Median Change From Baseline in Viral Load (Week 96)		Baseline to Week 96	No
Secondary	Virologic Response at Week 40	Virologic response defined as Viral Load<400 copies/mL	Week 40	No
Secondary	Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks	Virologic response defined as Viral Load<400 copies/mL	Week 2 through Week 96 (at any point during trial)	No
Secondary	Virologic Response at Week 2	Virologic response defined as Viral Load<400 copies/mL	Week 2	No
Secondary	Virologic Response at Week 4	Virologic response defined as Viral Load<400 copies/mL	Week 4	No
Secondary	Virologic Response at Week 8	Virologic response defined as Viral Load<400 copies/mL	Week 8	No
Secondary	Virologic Response at Week 16	Virologic response defined as Viral Load<400 copies/mL	Week 16	No
Secondary	Virologic Response at Week 24	Virologic response defined as Viral Load<400 copies/mL	Week 24	No
Secondary	Virologic Response at Week 32	Virologic response defined as Viral Load<400 copies/mL	Week 32	No
Secondary	Virologic Response at Week 48	Virologic response defined as Viral Load<400 copies/mL	Week 48	No
Secondary	Virologic Response at Week 56	Virologic response defined as Viral Load<400 copies/mL	Week 56	No
Secondary	Virologic Response at Week 64	Virologic response defined as Viral Load<400 copies/mL	Week 64	No
Secondary	Virologic Response at Week 72	Virologic response defined as Viral Load<400 copies/mL	Week 72	No
Secondary	Virologic Response at Week 80	Virologic response defined as Viral Load<400 copies/mL	Week 80	No
Secondary	Virologic Response at Week 88	Virologic response defined as Viral Load<400 copies/mL	week 88	No
Secondary	Virologic Response at Week 96	Virologic response defined as Viral Load<400 copies/mL	week 96	No
Secondary	Virologic Response	Virologic response defined as Viral Load<50 copies/mL	Week 2 through Week 96 (at any point during trial)	No
Secondary	Virologic Response at Week 2	Virologic response defined as Viral Load<50 copies/mL	Week 2	No
Secondary	Virologic Response at Week 4	Virologic response defined as Viral Load<50 copies/mL	Week 4	No
Secondary	Virologic Response at Week 8	Virologic response defined as Viral Load<50 copies/mL	Week 8	No
Secondary	Virologic Response at Week 16	Virologic response defined as Viral Load<50 copies/mL	Week 16	No
Secondary	Virologic Response at Week 24	Viral Load < 50 copies/mL	Week 24	No
Secondary	Virologic Response at Week 32	Virologic response defined as Viral Load<50 copies/mL	Week 32	No
Secondary	Virologic Response at Week 40	Virologic response defined as Viral Load<50 copies/mL	Week 40	No
Secondary	Virologic Response at Week 48	Virologic response defined as Viral Load<50 copies/mL	Week 48	No
Secondary	Virologic Response at Week 56	Virologic response defined as Viral Load<50 copies/mL	Week 56	No
Secondary	Virologic Response at Week 64	Virologic response defined as Viral Load<50 copies/mL	Week 64	No
Secondary	Virologic Response at Week 72	Virologic response defined as Viral Load<50 copies/mL	Week 72	No
Secondary	Virologic Response at Week 80	Virologic response defined as Viral Load<50 copies/mL	Week 80	No
Secondary	Virologic Response at Week 88	Virologic response defined as Viral Load<50 copies/mL	Week 88	No
Secondary	Virologic Response at Week 96	Virologic response defined as Viral Load<50 copies/mL	Week 96	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 2)		Baseline to Week 2	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 4)		Baseline to Week 4	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 8)		Baseline to Week 8	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 16)		Baseline to Week 16	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 24)		Baseline to Week 24	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 32)		Baseline to Week 32	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 40)		Baseline to Week 40	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 48)		Baseline to Week 48	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 56)		Baseline to Week 56	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 64)		Baseline to Week 64	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 72)		Baseline to Week 72	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 80)		Baseline to Week 80	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 88)		Baseline to Week 88	No
Secondary	Mean Change From Baseline in CD4+ Cell Count (Week 96)		Baseline to Week 96	No
Secondary	Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.	Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.; The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.	up to 75 weeks of treatment	No

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