Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

HIV Infection Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708162
• Other study ID #: GS-US-183-0145
• Secondary ID: 2007-004225-26
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2008
• Last updated: May 6, 2015
• Start date: July 2008
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardItaly: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Portugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir added to a background regimen (containing a fully-active ritonavir-boosted protease inhibitor [PI/r] and a second agent) in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (elvitegravir arm), or raltegravir plus background regimen (raltegravir arm).

Description:

Due to known drug interactions, participants who are taking ritonavir-boosted atazanavir (ATV/r) or lopinavir/r (LPV/r) as part of their background regimen will receive elvitegravir at a lower dose (85 mg) if randomized to the Elvitegravir Arm.

The background regimen will be constructed by the investigator based on viral resistance testing. The fully active PI will be defined by phenotypic resistance analysis. For phenotypic susceptibility, fully active is defined as being below the lower clinical or biological cutoff. Participants are required to take their ritonavir dose based on the dosing schedule indicated in the prescribing information for the PI; no additional ritonavir is required to be taken with EVG. No other marketed PIs are allowed as part of the background regimen due to unknown drug interactions.

The second agent can be one nucleoside or nucleotide reverse transcriptase inhibitor (NRTI), etravirine, maraviroc, or T-20. However, the second agent must not include an integrase inhibitor; the nonnucleoside reverse transcriptase inhibitors efavirenz, nevirapine, or delavirdine (due to unknown drug interactions); or the fixed-dose combination therapies Atripla® or Trizivir® (abacavir sulfate/lamivudine/zidovudine). The second agent may or may not be fully active (except in Spain, where participants have to receive a fully active second agent, as requested by the Spanish regulatory agency).

If the M184V/I reverse transcriptase (RT) mutation is present on the screening genotype report and an NRTI is used as the second agent, then either FTC or LAM may be added as a third agent in the background regimen to maintain the M184V/I mutation. In this situation only, the fixed-dose combination therapies Combivir®, Truvada®, or Epzicom/Kivexa® may be prescribed as the combined second and third agents of the background regimen.

After Week 96, participants will continue to take their blinded study drug and attend visits until treatment assignments are unblinded, at which point they will be given the option to participate in an open-label EVG extension phase of the study.

Other known NCT identifiers

• NCT00707733

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: April 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Plasma HIV-1 RNA levels = 1,000 copies/mL at screening

• Documented resistance or at least six months experience prior to screening with two or more different classes of antiretroviral agents

• Stable antiretroviral regimen for at least 30 days prior to screening: however, participants may discontinue the antiretroviral regimen after screening and remain off therapy until baseline at the discretion of the investigator

• Eligible to receive one of the fully-active ritonavir-boosted-PIs, and an allowed second agent

• Normal ECG

• Adequate renal function (estimated glomerular filtration rate according to the Cockcroft-Gault formula = 60 mL/min)

• Hepatic transaminases = 5 × upper limit of normal

• Total bilirubin = 1.5 mg/dL, or normal direct bilirubin

• Adequate hematologic function (absolute neutrophil count = 1,000/mm^3; platelets = 50,000/mm^3; hemoglobin = 8.5 g/dL)

• Serum amylase < 1.5 × the upper limit of the normal range

• Negative serum pregnancy test (females of childbearing potential only)

• Males and females of childbearing potential must agree to use highly effective contraception methods

• Age = 18 years

• Life expectancy = 1 year

• Ability to understand and sign a written informed consent form

Exclusion Criteria:

• New AIDS-defining condition diagnosed within the 30 days prior to screening

• Prior treatment with any HIV-1 integrase inhibitor

• Participants experiencing ascites

• Participants experiencing encephalopathy

• Females who are breastfeeding

• Positive serum pregnancy test at any time during the study (female of childbearing potential)

• Participants receiving ongoing therapy with any disallowed medication

• Current alcohol or substance use judged by the investigator to potentially interfere with study compliance

• Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma

• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline

• Participation in any other clinical trial (except for the etravirine or maraviroc expanded access program), without prior approval from sponsor

• Any other clinical condition or prior therapy that would make participants unsuitable for the study

• Known hypersensitivity to study drug, metabolites or formulation excipients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Elvitegravir
Elvitegravir 85 mg or 150 mg tablet administered orally once daily with food; dose level is dependent on which ritonavir-boosted protease inhibitor (PI/r) is administered as part of the background regimen.
• Raltegravir
Raltegravir 400 mg tablet administered orally twice daily according to prescribing information
• Placebo to match elvitegravir
Placebo to match elvitegravir administered orally once daily
• Placebo to match raltegravir
Placebo to match raltegravir administered orally twice daily.
• Background regimen
Background Regimen is administered according to prescribing information, and contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either atazanavir, darunavir, fosamprenavir, lopinavir (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Ground Zero Medical Centre	Darlinghurst	New South Wales
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital, Sydney	Darlinghurst	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	East Sidney Doctors	Sidney	New South Wales
Australia	Albion Street Centre	Sydney	New South Wales
Australia	Westmead Hospital	Wentworthville	New South Wales
Belgium	Institute of Tropical Medicine	Antwerp
Belgium	C.H.U. St Pierre	Brussels
Belgium	Hôpital Erasme	Brussels
Belgium	CHU de Charleroi-Hopital civil	Charleroi
Belgium	Centre Hospitalier Universitaire de Liège	Liege
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Clinique medicale l'Actuel	Montreal	Quebec
Canada	Immunodeficiency Service, McGill University Health Centre (MUHC)	Montreal	Quebec
Canada	Canadian Immunodeficiency Research Collaborative (CIRC) Inc.	Toronto	Ontario
Canada	CascAids Research	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
Canada	Downtown Infectious Diseases Clinic	Vancouver	British Columbia
Canada	University of Manitoba - Health Sciences Centre	Winnipeg
France	Hopital de Bicentre - Service de medecine Interne et Immunologie	Le Kremlin Bicetre
France	University Hospital of Montpellier - Gui de Chauliac	Montpellier
France	CHU Nantes	Nantes
France	C.H.U. de Nice - Hopital de l'Archet 1	Nice
France	APHP Hopital Bichat-Claude Bernard	Paris
France	Hopital Pitie Salpetriere - Infectious Deseases Department	Paris
France	Hopital Saint Antoine - Infectious Desease Department	Paris
France	Hopital Saint Louis	Paris
France	Hopital Tenon	Paris
France	CHU Bordeaux	Pessac
France	Hopital Purpan - Service of Infectious Diseases	Toulouse
Germany	Universitatsklinikum Bonn	Bonn
Germany	Universitatsklinikum Dusseldorf	Dusseldorf
Germany	Universitatklinikum Essen	Essen
Germany	Klinikum der J.W. Goethe-Universitat	Frankfurt
Germany	Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf	Hamburg
Germany	IFI-Institute	Hamburg
Germany	Medizinische Universitatsklinik Kiel	Kiel
Germany	Klinikum der Universitat zu Koln	Koln
Germany	MUC Research	Munich
Italy	Ospedali Riuniti Di Bergamo	Bergamo
Italy	Spedali Civili di Brescia	Brescia
Italy	Fondazione Centro San Raffaele del Monte Tabor	Milan
Italy	Ospedale L. Sacco	Milan
Italy	Ospedale Luigi Sacco	Milan
Italy	Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.	Rome
Italy	Universita La Sapienza Policlinico Umberto I	Rome
Italy	Universita' Cattolica Del Sacro Cuore	Rome
Mexico	Hospital Civil de Guadalajara	Guadalajara	Jalisco
Mexico	Hospital Regional de Leon Guanajuato	Leon	Guanajuato
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)	Mexico	D.f.
Mexico	Hospital Central Morones Prieto	San Luis Potosi	San Luis Potsi
Netherlands	Erasmus Medisch Centrum	Rotterdam
Portugal	Hospital Fernando Fonseca	Amadora
Portugal	Hospital de Santa Maria	Lisbon
Portugal	Hospital Pulido Valente	Lisbon
Portugal	Hospital Santo Antonio dos Capuchos	Lisbon
Portugal	Hospital de Sao Joao	Porto
Puerto Rico	Instituto de Investigacion Cientifica del Sur	Ponce
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
Puerto Rico	HOPE Clinical Research	San Juan
Puerto Rico	University of Puerto Rico, School of Medicine, Proyecto ACTU	San Juan
Puerto Rico	VA Caribbean healthcare System	San Juan
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital General Universitario del Elche	Elche
Spain	Hospital Clinico San Cecilio	Granada
Spain	Hospital Doce De Octubre	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Complexo Hospitalario Xeral-Cies (Chuvi) Vigo	Vigo
Switzerland	Universitatsspital Zurich	Zurich
United Kingdom	RIDU, Western General Hospital	Edinburgh
United Kingdom	Imperial College Healthcare NHS Trust, St. Mary's Campus	London
United Kingdom	Royal Free and University College Medical School	London
United Kingdom	North Manchester General Hospital	Manchester
United States	Summa Health CARE Center	Akron	Ohio
United States	Albany Medical College	Albany	New York
United States	Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Atlanta ID Group	Atlanta	Georgia
United States	The Emory Clinic, Inc., Division of Infectious Diseases	Atlanta	Georgia
United States	South Florida Clinical Research	Atlantis	Florida
United States	Central Texas Clinical Research	Austin	Texas
United States	University of Maryland, Institute of Human Virology	Baltimore	Maryland
United States	Be Well Medical Center	Berkley	Michigan
United States	AIDS Healthcare Foundation-Research Center	Beverly Hills	California
United States	Pacific Oaks Medical Group	Beverly Hills	California
United States	Community Research Initiative of New England	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	STAR Health Care Center	Brooklyn	New York
United States	University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Northstar Medical Center	Chicago	Illinois
United States	The Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	AIDS Arms/ Peabody Health Center	Dallas	Texas
United States	North Texas Infectious Disease Consultants	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Southwest Infectious Disease Clinical Research	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta (IDSA)	Decatur	Georgia
United States	Henry Ford Hospital Div of Infectious Disease	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	Broward Health CCC	Fort Lauderdale	Florida
United States	Gary Richmond, MD, PA, Inc.	Fort Lauderdale	Florida
United States	Lifeway , Inc.	Fort Lauderdale	Florida
United States	NorthPoint Medical	Fort Lauderdale	Florida
United States	Therafirst Medical Centers	Fort Lauderdale	Florida
United States	Associates In Infectious Diseases	Fort Pierce	Florida
United States	Tarrant County Infectious Disease Associates	Fort Worth	Texas
United States	Center for Special Immunology	Fountain Valley	California
United States	Connecticut Health Care Group	Glastonbury	Connecticut
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina
United States	Garcia Family Health Group	Harlingen	Texas
United States	ID Care	Hillsborough	New Jersey
United States	Hawaii AIDS Clinical Research Program HACRP	Honolulu	Hawaii
United States	Gordon E. Crofoot, MD, PA	Houston	Texas
United States	Joseph C. Gathe, JR. MD, F.A.C.P.	Houston	Texas
United States	The Schrader Clinic	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Rosedale Infectious Diseases	Huntersville	North Carolina
United States	University of Kentucky Healthcare/Bluegrass Care Clinic	Lexington	Kentucky
United States	Health for Life Clinic, PLLC	Little Rock	Arkansas
United States	The Living Hope Foundation	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Jeffrey Goodman Special Care Clinic	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	Peter J. Ruane, MD, Inc.	Los Angeles	California
United States	Tony Mills, MD Internal Medicine	Los Angeles	California
United States	University of Southern California, AIDS Clinical Trials Unit	Los Angeles	California
United States	Mercer Univ. School of Medicine	Macon	Georgia
United States	The Kinder Medical Group	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Greiger Clinic	Mt. Vernon	New York
United States	Beth Israel Medical Center	New York	New York
United States	Chelsea Village Medical, PC	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Ricky K. Hsu, MD, PC	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice	Newark	New Jersey
United States	Orange Coast Medical Group	Newport Beach	California
United States	Wohlfeiler, Piperato and Associates, LLC	North Miami Beach	Florida
United States	Circle Medical LLC	Norwalk	Connecticut
United States	Alameda County Medical Center	Oakland	California
United States	East Bay AIDS Center	Oakland	California
United States	Infectious Disease of Central Florida	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Jefferson Alumni Hall	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Southwest Center for HIV/AIDS	Phoenix	Arizona
United States	AIDS Community HealthCenter	Rochester	New York
United States	Kaiser Permanente	Sacramento	California
United States	Barry M. Rodwick, M. D.	Safety Harbor	Florida
United States	David J. Shamblaw, MD Inc.	San Diego	California
United States	Metropolis Medical	San Francisco	California
United States	San Francisco VA Medical Center/UCSF	San Francisco	California
United States	Southwest C.A.R.E. Center	Santa Fe	New Mexico
United States	Chatham County Health Department	Savannah	Georgia
United States	South Jersey Infectious Disease	Somer Point	New Jersey
United States	EHS Pulmonary and Critical Care	Spokane	Washington
United States	Southampton Healthcare, Inc.	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	The Stamford Hospital - Stamford ID	Stamford	Connecticut
United States	St. Joseph's Comprehensive Research Institute	Tampa	Florida
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida
United States	The George Washington University Medical Center	Washington	District of Columbia
United States	Whitman-Walker Clinic	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Mexico,  Netherlands,  Portugal,  Puerto Rico,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 rece — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 48	No
Secondary	Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 96	No
Secondary	Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 48	No
Secondary	Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 96	No
Secondary	Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)	Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 48	No
Secondary	Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)	Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.	Week 96	No
Secondary	Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48	The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.	Baseline to Week 48	No
Secondary	Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96	The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.	Baseline to Week 96	No
Secondary	Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48	The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.	Baseline to Week 48	No
Secondary	Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96	The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.	Baseline to Week 96	No
Secondary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.	Week 48	No
Secondary	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.	Week 96	No
Secondary	Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.	Week 48	No
Secondary	Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96	The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.	Week 96	No
Secondary	Change From Baseline in HIV-1 RNA at Week 48	The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.	Baseline to Week 48	No
Secondary	Change From Baseline in HIV-1 RNA at Week 96	The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.	Baseline to Week 96	No
Secondary	Change From Baseline in CD4 Cell Count at Week 48	The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.	Baseline to Week 48	No
Secondary	Change From Baseline in CD4 Cell Count at Week 96	The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.	Baseline to Week 96	No