Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
NCT ID: NCT00830804
Last Updated: 2018-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2009-04-30
2010-09-30
Brief Summary
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Detailed Description
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The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.
After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.
RAL and DRV were provided by the study. RTV was not provided by the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAL + DRV/RTV
Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Raltegravir
400 mg tablet taken orally twice daily
Darunavir/Ritonavir
800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
Interventions
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Raltegravir
400 mg tablet taken orally twice daily
Darunavir/Ritonavir
800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
* HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
* ARV drug-naive. More information on this criterion can be found in the protocol.
* Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
* Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.
Exclusion Criteria
* Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation \[RAM\] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
* Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
* Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
* Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
* Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.
* Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.
* Certain abnormal laboratory results. More information on this criterion can be found in the protocol.
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Joseph J. Eron, Jr., MD
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Locations
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AlabamaTherapeutics CRS
Birmingham, Alabama, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Georgetown University CRS
Washington D.C., District of Columbia, United States
Northwestern University CRS
Chicago, Illinois, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
AIDS Community Health Ctr. ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CTU
Pittsburgh, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
Houston AIDS Research Team
Houston, Texas, United States
Countries
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References
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Capetti AF, Piconi S, Landonio S, Rizzardini G, Perno CF. Is dual therapy with raltegravir and protease inhibitors a feasible option in rescue strategy in HIV-1 infection? J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4. doi: 10.1097/QAI.0b013e31818c7e8e. No abstract available.
Long MC, King JR, Acosta EP. Pharmacologic aspects of new antiretroviral drugs. Curr HIV/AIDS Rep. 2009 Feb;6(1):43-50. doi: 10.1007/s11904-009-0007-y.
Vermeir M, Lachau-Durand S, Mannens G, Cuyckens F, van Hoof B, Raoof A. Absorption, metabolism, and excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects. Drug Metab Dispos. 2009 Apr;37(4):809-20. doi: 10.1124/dmd.108.024109. Epub 2009 Jan 8.
Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, Berzins BI, Acosta EP, Bastow B, Kim PS, Eron JJ Jr; ACTG A5262 Team. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011 Nov 13;25(17):2113-22. doi: 10.1097/QAD.0b013e32834bbaa9.
Other Identifiers
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ACTG A5262
Identifier Type: -
Identifier Source: org_study_id
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