Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
NCT ID: NCT00711009
Last Updated: 2012-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2008-07-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LPV/r + FTC/TDF
lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC/TDF 200/300 mg QD
LPV/r + RAL
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
raltegravir (RAL)
RAL 400 mg BID
Interventions
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lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC/TDF 200/300 mg QD
raltegravir (RAL)
RAL 400 mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.
* Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.
* Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.
* Participant does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Participant agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the principal investigator.
* Female participants must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the participant and investigator. All female participants must have a urine pregnancy test performed at screening visit and on Day minus 1/baseline, and results of both tests must be negative. Female participants may not be breastfeeding.
* Participants have received no prior treatment with an HIV-1 integrase inhibitor.
Exclusion Criteria
* Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
* Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
* Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
* Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
* Participants may not have any of the following abnormal screening results: Hemoglobin \<= 8.0 grams/deciliter, absolute neutrophil count \<= 750 cells/microliter, Platelet count \<= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \>= 3.0 x upper limit of normal (ULN), calculated creatinine clearance \< 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.
* The investigator considers the participant to be an unsuitable candidate for the study.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas J Podsadecki, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 7689
Barcelona, , Spain
Site Reference ID/Investigator# 8431
Phoenix, Arizona, United States
Site Reference ID/Investigator# 8432
Beverly Hills, California, United States
Site Reference ID/Investigator# 8394
Atlantis, Florida, United States
Site Reference ID/Investigator# 8393
Ft. Pierce, Florida, United States
Site Reference ID/Investigator# 8425
Orlando, Florida, United States
Site Reference ID/Investigator# 8402
Tampa, Florida, United States
Site Reference ID/Investigator# 8396
Vero Beach, Florida, United States
Site Reference ID/Investigator# 8395
Atlanta, Georgia, United States
Site Reference ID/Investigator# 8429
Decatur, Georgia, United States
Site Reference ID/Investigator# 8424
Boston, Massachusetts, United States
Site Reference ID/Investigator# 8426
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 11461
Huntersville, North Carolina, United States
Site Reference ID/Investigator# 8403
Dallas, Texas, United States
Site Reference ID/Investigator# 8433
Houston, Texas, United States
Site Reference ID/Investigator# 7963
Ottawa, Ontario, Canada
Site Reference ID/Investigator# 7831
Toronto, Ontario, Canada
Site Reference ID/Investigator# 7959
Toronto, Ontario, Canada
Site Reference ID/Investigator# 8099
Montreal, Quebec, Canada
Site Reference ID/Investigator# 7695
Lyon, , France
Site Reference ID/Investigator# 7960
Montpellier, , France
Site Reference ID/Investigator# 8063
Paris, , France
Site Reference ID/Investigator# 7821
Paris, , France
Site Reference ID/Investigator# 8052
Genoa, , Italy
Site Reference ID/Investigator# 7789
Milan, , Italy
Site Reference ID/Investigator# 8051
Perugia, , Italy
Site Reference ID/Investigator# 8050
Rome, , Italy
Site Reference ID/Investigator# 8221
Wroclaw, , Poland
Site Reference ID/Investigator# 7713
Bayamón, , Puerto Rico
Site Reference ID/Investigator# 7700
Ponce, , Puerto Rico
Site Reference ID/Investigator# 11102
Barcelona, , Spain
Site Reference ID/Investigator# 7697
Barcelona, , Spain
Site Reference ID/Investigator# 7692
L'Hospitalet de Llobregat, , Spain
Site Reference ID/Investigator# 7698
Madrid, , Spain
Site Reference ID/Investigator# 7693
Madrid, , Spain
Site Reference ID/Investigator# 7691
Madrid, , Spain
Site Reference ID/Investigator# 7690
Seville, , Spain
Countries
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References
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Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3.
Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
Related Links
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Other Identifiers
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2008-000881-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M10-336
Identifier Type: -
Identifier Source: org_study_id
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