Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV
NCT ID: NCT00090779
Last Updated: 2018-10-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
130 participants
INTERVENTIONAL
2005-01-31
2011-05-31
Brief Summary
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Detailed Description
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The original study lasted 96 weeks. Participants were randomly assigned to one of two groups (IT arm vs. DT arm). For the first 36 weeks of the study, IT arm participants received FTC/TDF once daily and LPV/RTV twice daily. Some IT arm participants received a different ART regimen as determined by the participant and study staff, if appropriate. DT arm participants received no treatment for the duration of the study. At Week 37, participants from both arms were offered treatment continuation or initiation until Week 96 if they had a high viral load, low CD4 count, or experienced HIV-related symptoms (Step 2). Study visits occurred at screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical assessment and blood collection occurred at all visits. Urine tests occurred at selected visits. Participants were asked to complete an adherence questionnaire at Weeks 12, 24, and 36.
Per the recommendations the DSMB review in June 2009, this protocol was terminated as originally written with the exception of those participants in the IT arm in the middle of the first 36 weeks of treatment. Those participants were to continue on treatment until the end of the 36 weeks. At that point treatment decisions were made on best practice guidelines. In addition, the study duration was extended to include a 5 year follow up of participants who did not initiate long-term antiretroviral therapy (Step 3).
The study was reviewed by an SMC on December 8, 2010. The SMC recommended the study close to long term follow-up because only very few participants enrolled in this portion of the study.
All the results except for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on July 2, 2009. The results for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on January 30, 2012.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IT arm
IT (immediate treatment) arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
Emtricitabine/ tenofovir disoproxil fumarate
once daily
Lopinavir/Ritonavir
twice daily
DT arm
DT (deferred treatment) arm participants received no treatment
No interventions assigned to this group
Interventions
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Emtricitabine/ tenofovir disoproxil fumarate
once daily
Lopinavir/Ritonavir
twice daily
Eligibility Criteria
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Inclusion Criteria
* No prior antiretroviral therapy (ART)
* CD4 count of 350 cells/mm3 or more AND a CD4% of 14% or more within 21 days prior to study entry
* HIV viral load of 500 copies/ml or more within 21 days prior to study entry
* Required laboratory values obtained within 21 days prior to study entry
* 18 years or older
* Ability and willingness to provide written informed consent
* Willing to use acceptable forms of contraception
* subjects in DT arm who meet one of the following five criteria will be advised to enter step 2 and initiate ART:
1. CD4 cell counts below 350 cells/mm3 on 2 consecutive determinations at least 4 weeks apart at or after the step 1, week 12 study visit
2. HIV-1 RNA above 750,000 copies/mL confirmed on 2 consecutive determinations at least 1 week apart at or after the step 1, week 4 study visit
3. HIV-1 RNA above 200,000 copies/mL on 2 consecutive determinations at least 1 week apart at or after the step 1, week 12 study visit
4. Clinical progression to CDC category B or C disease
5. CD4 count below 200 cells/mm3 or CD4 percent less than 14% at any time on study
* subjects in IT arm who meet one of the following five criteria after discontinuing study medications will be advised to enter step 2 and re-initiate ART:
1. CD4 cell counts below 350 cells/mm3 on 2 consecutive determinations at least 4 weeks apart at or after the step 1, week 12 post-treatment- discontinuation study visit
2. HIV-1 RNA above 750,000 copies/mL confirmed on 2 consecutive determinations at least 1 week apart at or after the step 1, week 4 post-treatment- discontinuation study visit
3. HIV-1 RNA above 200,000 copies/mL on 2 consecutive determinations at least 1 week apart at or after the step 1, week 12 post-treatment- discontinuation study visit
4. Clinical progression to CDC category B or C disease
5. CD4 count below 200 cells/mm3 or CD4 percent less than 14% at any time on study
* Study participants who were on Step 1, IT arm and had completed or ended prematurely the 36 week course of early ART and did not on ART either because they did not meet eligibility criteria for Step 2 or because they did not start ART even after meeting the Step 2 eligibility criteria.
* Study participants on Step 1, DT arm who were not on ART either because they did not meet eligibility criteria for Step 2 or because they did not start ART even after meeting the Step 2 eligibility criteria.
* Previous A5217 participants who had either completed the study or ended prematurely their participation in the study, AND were not on ART either because they never met eligibility criteria for Step 2 or because they had not started ART even after meeting the Step 2 eligibility criteria.
* All A5217 participants who were on Step 1 and in the midst of their 36 weeks of randomized ART and who completed a portion or all of the 36 weeks of originally recommended therapy, AND chose then to interrupt their ART.
Exclusion Criteria
* Pregnancy or breastfeeding
* History of pancreatitis or coronary artery disease
* Prior ART. Participants who took antiretrovirals for postexposure prophylaxis more than one year prior to study entry are not excluded.
* Certain medications within 21 days prior to study entry. Participants who agree to receive an alternative ART regimen approved by the investigator will not be excluded.
* Previously received an investigational anti-HIV vaccine
* Current therapy with systemic corticosteroids. Patients who are taking a short course (less than 21 days) of corticosteroids are not excluded.
* Current therapy with systemic chemotherapeutic agents; nephrotoxic systemic agents; immunomodulatory treatments, including interleukin-2; or investigational agents
* Known allergy or sensitivity to study drugs or their formulations
* Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
* Serious medical or psychiatric illness that, in the opinion of the investigator, would interfere with the study
* Hepatitis B surface antigen positive within 21 days prior to study entry
* Known resistance to one or more components of the study drug regimen
* Pregnancy or breastfeeding
* Participants who were on Step 1, IT arm of the study receiving ART.
* Participants in Step 2 or who had otherwise initiated long-term ART, regardless of whether they were on treatment.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Adult AIDS Clinical Trials Group
NETWORK
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Christine Hogan, MD
Role: STUDY_CHAIR
Division of Infectious Diseases, Columbia University College of Physicians and Surgeons
Locations
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Ucsd, Avrc Crs (701)
San Diego, California, United States
Ucsf Aids Crs (801)
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
University of Miami AIDS CRS (901)
Miami, Florida, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago, Illinois, United States
Indiana University Hospital (2601)
Indianapolis, Indiana, United States
IHV Baltimore Treatment CRS (4651)
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, United States
Washington University CRS (2101)
St Louis, Missouri, United States
Beth Israel Medical Center
New York, New York, United States
HIV Prevention & Treatment CRS (30329)
New York, New York, United States
AIDS Care CRS (1108)
Rochester, New York, United States
University of Rochester ACTG CRS (1101)
Rochester, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
Moses H. Cone Memorial Hospital CRS (3203)
Greensboro, North Carolina, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS (3203)
Greensboro, North Carolina, United States
The Ohio State Univ. AIDS CRS (2301)
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, United States
The Miriam Hosp. ACTG CRS (2951)
Providence, Rhode Island, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, United States
UW Primary Infection Clinic CRS (1404)
Seattle, Washington, United States
San Miguel CRS
San Miguel, Lima region, Peru
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, , Peru
Countries
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References
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Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54. doi: 10.1097/00002030-200210180-00010.
Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.
Little SJ, Holte S, Routy JP, Daar ES, Markowitz M, Collier AC, Koup RA, Mellors JW, Connick E, Conway B, Kilby M, Wang L, Whitcomb JM, Hellmann NS, Richman DD. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med. 2002 Aug 8;347(6):385-94. doi: 10.1056/NEJMoa013552.
Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
Messer K, Vaida F, Hogan C. Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217. Contemp Clin Trials. 2006 Dec;27(6):506-17. doi: 10.1016/j.cct.2006.07.003. Epub 2006 Jul 25.
Hogan CM, Degruttola V, Sun X, Fiscus SA, Del Rio C, Hare CB, Markowitz M, Connick E, Macatangay B, Tashima KT, Kallungal B, Camp R, Morton T, Daar ES, Little S; A5217 Study Team. The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals. J Infect Dis. 2012 Jan 1;205(1):87-96. doi: 10.1093/infdis/jir699. Epub 2011 Dec 15.
Related Links
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Click here for more information about the AIEDRP CORE01 study
Other Identifiers
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AIEDRP AIN503
Identifier Type: -
Identifier Source: secondary_id
ACTG A5217
Identifier Type: -
Identifier Source: secondary_id
ACTG A5217
Identifier Type: -
Identifier Source: org_study_id
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