Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
NCT ID: NCT00851799
Last Updated: 2016-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
334 participants
OBSERVATIONAL
2009-06-30
2013-06-30
Brief Summary
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A5260s was designed to examine the contributions of HIV-disease related factors and impact of newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV) and how well these drug combinations work to decrease the amount of HIV in the blood and to allow immune system recovery in people who have never received anti-HIV therapy. A5257 also examined drug tolerability and safety for the various drug combinations.
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Detailed Description
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Some participants in study A5257 were asked to participate in substudy A5260s. Not all participants were asked since A5260s only took place at a subset of A5257 sites. Participants who agreed to participate in substudy A5260s were enrolled at the same time as their enrollment in A5257. No interventions were given as part of A5260s, but all A5260s participants underwent blood draws, self-administered questionnaire responses (related to physical activity and body image), ultrasound scans to measure the thickness of the carotid artery in the neck and brachial artery flow mediated dilation in the arm, and computerized topography (CT) and dual-energy x-ray absorptiometry (DEXA) scans to measure bone mineral density and body fat.
The duration of A5260s study was between 2 and 3 years (96 and 144 weeks), depending on when the participant enrolled. The study was designed to enroll a total of 330 participants with at least 110 per a group; each group represented a different randomized drug combination as defined and assigned by the main study A5257.
Cohort A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Cohort B: Raltegravir (RAL) + FTC/TDF
Cohort C: Darunavir (DRV) + RTV + FTC/TDF
All participants were asked to return for A5260s clinic visits at weeks 4, 24, 48 96 and 144 and participated in all clinical evaluations. No clinical evaluation was restricted to a subset of A5260s participants. If a participant chose to discontinue participation in the substudy, the participant was able to continue in study A5257. However, a participant discontinuing participation from A5257 was also removed from A5260s. Additionally, a participant's decision to discontinue or switch study drugs in the main study did not impact participation and follow-up clinic visits in A5260s.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
ATV/RTV + FTC/TDF
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
Other Name: TDF/FTC
Ritonavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Atazanavir
300 mg taken orally once daily. A protease inhibitor (PI).
Other Name: ATV
Cohort B
RAL + FTC/TDF
FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Emtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
Other Name: TDF/FTC
Ritonavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Raltegravir
400 mg taken orally twice daily. An integrase inhibitor (INI).
Other Name: RAL
Cohort C
DRV/RTV + FTC/TDF
FTC/TDF, darunavir (DRV), and RTV, orally, once daily.
Emtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
Other Name: TDF/FTC
Ritonavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Darunavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Interventions
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Emtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
Other Name: TDF/FTC
Ritonavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Atazanavir
300 mg taken orally once daily. A protease inhibitor (PI).
Other Name: ATV
Raltegravir
400 mg taken orally twice daily. An integrase inhibitor (INI).
Other Name: RAL
Darunavir
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Known cardiovascular disease (history of myocardial infarction \[MI\], coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, or peripheral arterial disease with ankle-brachial index of less than 0.9 or claudication)
* Uncontrolled hypothyroidism or hyperthyroidism which in the opinion of the site investigator would affect substudy participation
* Current use of statins, fish oil (greater than 2 grams per day), fibric acid derivatives, or niacin (more than 1000 mg per day) (NOTE: Current use of fish oil and niacin is defined as receiving treatment in the 8 weeks prior to study entry)
* Intention to start pharmacological or surgical intervention for weight loss
* Use of any ART in the 30 days before study entry
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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Todd Brown, MD, PhD
Role: STUDY_CHAIR
Johns Hopkins University
James Stein, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Grace McComsey, MD, FIDSA
Role: STUDY_CHAIR
University Hospitals Cleveland Medical Center
Judith Currier, MD, MSc
Role: STUDY_CHAIR
UCLA AIDS Prevention & Treatment CTU
Locations
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USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Harbor - UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
The Ponce de Leon Center
Atlanta, Georgia, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
Rush University Medical Center (2702)
Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Washington University CRS (2101)
St Louis, Missouri, United States
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States
AIDS Care CRS
Rochester, New York, United States
University of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS (1601)
Durham, North Carolina, United States
University of Cincinnati CRS (2401)
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
Metro Health CRS
Cleveland, Ohio, United States
The Ohio State University AIDS CRS (2301)
Colombus, Ohio, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
Houston AIDS Research Team CRS (31473)
Houston, Texas, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, United States
Countries
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References
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Lennox JL, Landovitz RJ, Ribaudo HJ, Ofotokun I, Na LH, Godfrey C, Kuritzkes DR, Sagar M, Brown TT, Cohn SE, McComsey GA, Aweeka F, Fichtenbaum CJ, Presti RM, Koletar SL, Haas DW, Patterson KB, Benson CA, Baugh BP, Leavitt RY, Rooney JF, Seekins D, Currier JS; ACTG A5257 Team. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med. 2014 Oct 7;161(7):461-71. doi: 10.7326/M14-1084.
Ofotokun I, Na LH, Landovitz RJ, Ribaudo HJ, McComsey GA, Godfrey C, Aweeka F, Cohn SE, Sagar M, Kuritzkes DR, Brown TT, Patterson KB, Para MF, Leavitt RY, Villasis-Keever A, Baugh BP, Lennox JL, Currier JS; AIDS Clinical Trials Group (ACTG) A5257 Team. Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257. Clin Infect Dis. 2015 Jun 15;60(12):1842-51. doi: 10.1093/cid/civ193. Epub 2015 Mar 12.
Vardhanabhuti S, Ribaudo HJ, Landovitz RJ, Ofotokun I, Lennox JL, Currier JS, Olson LM, Haas DW. Screening for UGT1A1 Genotype in Study A5257 Would Have Markedly Reduced Premature Discontinuation of Atazanavir for Hyperbilirubinemia. Open Forum Infect Dis. 2015 Jul 1;2(3):ofv085. doi: 10.1093/ofid/ofv085. eCollection 2015 Sep.
Stein JH, Ribaudo HJ, Hodis HN, Brown TT, Tran TT, Yan M, Brodell EL, Kelesidis T, McComsey GA, Dube MP, Murphy RL, Currier JS. A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness. AIDS. 2015 Sep 10;29(14):1775-83. doi: 10.1097/QAD.0000000000000762.
Kelesidis T, Tran TT, Stein JH, Brown TT, Moser C, Ribaudo HJ, Dube MP, Murphy R, Yang OO, Currier JS, McComsey GA. Changes in Inflammation and Immune Activation With Atazanavir-, Raltegravir-, Darunavir-Based Initial Antiviral Therapy: ACTG 5260s. Clin Infect Dis. 2015 Aug 15;61(4):651-60. doi: 10.1093/cid/civ327. Epub 2015 Apr 22.
Brown TT, Moser C, Currier JS, Ribaudo HJ, Rothenberg J, Kelesidis T, Yang O, Dube MP, Murphy RL, Stein JH, McComsey GA. Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir. J Infect Dis. 2015 Oct 15;212(8):1241-9. doi: 10.1093/infdis/jiv194. Epub 2015 May 5.
Stein JH, Brown TT, Ribaudo HJ, Chen Y, Yan M, Lauer-Brodell E, McComsey GA, Dube MP, Murphy RL, Hodis HN, Currier JS. Ultrasonographic measures of cardiovascular disease risk in antiretroviral treatment-naive individuals with HIV infection. AIDS. 2013 Mar 27;27(6):929-937. doi: 10.1097/QAD.0b013e32835ce27e.
Brown TT, Chen Y, Currier JS, Ribaudo HJ, Rothenberg J, Dube MP, Murphy R, Stein JH, McComsey GA. Body composition, soluble markers of inflammation, and bone mineral density in antiretroviral therapy-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):323-30. doi: 10.1097/QAI.0b013e318295eb1d.
Hughey CM, Vuong BW, Ribaudo HB, Mitchell CCK, Korcarz CE, Hodis HN, Currier JS, Stein JH. Grayscale Ultrasound Texture Features of Carotid and Brachial Arteries in People With HIV Infection Before and After Antiretroviral Therapy. J Am Heart Assoc. 2022 Mar;11(5):e024142. doi: 10.1161/JAHA.121.024142. Epub 2022 Feb 18.
Debroy P, Lake JE, Moser C, Olefsky M, Erlandson KM, Scherzinger A, Stein JH, Currier JS, Brown TT, McComsey GA. Antiretroviral Therapy Initiation Is Associated With Decreased Visceral and Subcutaneous Adipose Tissue Density in People Living With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Mar 15;72(6):979-986. doi: 10.1093/cid/ciaa196.
McComsey GA, Moser C, Currier J, Ribaudo HJ, Paczuski P, Dube MP, Kelesidis T, Rothenberg J, Stein JH, Brown TT. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s. Clin Infect Dis. 2016 Apr 1;62(7):853-62. doi: 10.1093/cid/ciw017. Epub 2016 Jan 20.
Other Identifiers
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ACTG A5257 metabolic substudy
Identifier Type: -
Identifier Source: secondary_id
ACTG A5260s
Identifier Type: -
Identifier Source: org_study_id
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