Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
NCT ID: NCT00660972
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2008-05-31
2010-04-30
Brief Summary
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Detailed Description
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This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.
This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Oral RAL and FTC/TDF for 72 weeks
Raltegravir
400 mg tablet taken orally twice daily
Emtricitabine/tenofovir disoproxil fumarate
Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
Interventions
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Raltegravir
400 mg tablet taken orally twice daily
Emtricitabine/tenofovir disoproxil fumarate
Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Antiretroviral treatment naive
* Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
* Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
Exclusion Criteria
* Received immunizations within 6 months prior to study entry
* Known allergy or sensitivity to study drugs
* Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
* Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
* Evidence of HIV seroconversion within 6 months prior to study entry
* Illness requiring systemic treatment and/or hospitalization
* Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
* Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
* Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
* Abnormal laboratory values. More information on this criterion can be found in the protocol.
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Adult AIDS Clinical Trials Group
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Adriana Andrade, MD, MPH
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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UCSD Antiviral Research Center CRS
San Diego, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Northwestern University CRS
Chicago, Illinois, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
Harlem ACTG CRS
New York, New York, United States
Trillium Health ACTG CRS
Rochester, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
MetroHealth CRS
Cleveland, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Providence, Rhode Island, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
Countries
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References
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Evering TH, Markowitz M. Raltegravir: an integrase inhibitor for HIV-1. Expert Opin Investig Drugs. 2008 Mar;17(3):413-22. doi: 10.1517/13543784.17.3.413.
Sedaghat AR, Dinoso JB, Shen L, Wilke CO, Siliciano RF. Decay dynamics of HIV-1 depend on the inhibited stages of the viral life cycle. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4832-7. doi: 10.1073/pnas.0711372105. Epub 2008 Mar 24.
Funderburg NT, Xu D, Playford MP, Joshi AA, Andrade A, Kuritzkes DR, Lederman MM, Mehta NN. Treatment of HIV infection with a raltegravir-based regimen increases LDL levels, but improves HDL cholesterol efflux capacity. Antivir Ther. 2017;22(1):71-75. doi: 10.3851/IMP3091. Epub 2016 Oct 14.
Funderburg NT, Andrade A, Chan ES, Rosenkranz SL, Lu D, Clagett B, Pilch-Cooper HA, Rodriguez B, Feinberg J, Daar E, Mellors J, Kuritzkes D, Jacobson JM, Lederman MM. Dynamics of immune reconstitution and activation markers in HIV+ treatment-naive patients treated with raltegravir, tenofovir disoproxil fumarate and emtricitabine. PLoS One. 2013 Dec 18;8(12):e83514. doi: 10.1371/journal.pone.0083514. eCollection 2013.
Other Identifiers
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10532
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5248
Identifier Type: -
Identifier Source: secondary_id
A5248
Identifier Type: -
Identifier Source: org_study_id