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
NA
36 participants
INTERVENTIONAL
2004-07-31
2006-05-31
Brief Summary
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Hypothesis: Simplified maintenance therapy with ATV and RTV alone after virologic suppression does not markedly increase the risk of virologic failure.
Detailed Description
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This study will last 54 weeks. Participants will undergo an electrocardiogram (EKG) at screening. At study start, participants will switch from their current PIs to ATV/RTV and stay on their current NRTIs until Week 6, when they will discontinue their NRTIs and remain on a maintenance regimen of ATV/RTV alone for the duration of the study. Study visits will take place at Weeks 3 and 6, then every 4 weeks until Week 30, then every 8 weeks until the end of the study at Week 54. Medication assessment, physical exam, and blood work will occur at each study visit. At Week 30, viral load will be measured in the genital secretions of both male and female study participants.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Atazanavir
Ritonavir
Eligibility Criteria
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Inclusion Criteria
* On first antiretroviral regimen, including at least 2 NRTIs and 1 PI, for at least 48 weeks immediately prior to study entry
* CD4 count of 250 cells/mm3 or greater
* Viral load less than 50 copies/ml within 30 days prior to entry
* Willing to use acceptable methods of contraception
Exclusion Criteria
* Certain PI mutations
* Hepatitis B infection within 90 days prior to study entry
* Certain therapies or medications within 30 days prior to study entry
* Heartbeat abnormalities or symptoms potentially related to heart block, such as unexplained fainting, dizziness, or palpitations, occurring within 180 days prior to study entry
* Drug or alcohol use or dependence that would interfere with adherence to the study requirements
* Serious illness requiring systemic treatment or hospitalization until the participant either completes therapy or has been clinically stable on therapy for at least 14 days prior to study entry
* Allergy or sensitivity to study medications or their formulations
* Current involuntarily incarceration for treatment of either a mental or physical illness
* Treatment for an active AIDS-defining opportunistic infection within 30 days prior to screening
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Susan Swindells, MD
Role: STUDY_CHAIR
University of Nebraska
Locations
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Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States
Weill Cornell Chelsea CRS
New York, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Cincinnati CRS
Cincinnati, Ohio, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States
Dallas VAMC
Dallas, Texas, United States
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, , Puerto Rico
Countries
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References
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Havlir DV, Marschner IC, Hirsch MS, Collier AC, Tebas P, Bassett RL, Ioannidis JP, Holohan MK, Leavitt R, Boone G, Richman DD. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team. N Engl J Med. 1998 Oct 29;339(18):1261-8. doi: 10.1056/NEJM199810293391801.
Pialoux G, Raffi F, Brun-Vezinet F, Meiffredy V, Flandre P, Gastaut JA, Dellamonica P, Yeni P, Delfraissy JF, Aboulker JP. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1-infected patients. Trilege (Agence Nationale de Recherches sur le SIDA 072) Study Team. N Engl J Med. 1998 Oct 29;339(18):1269-76. doi: 10.1056/NEJM199810293391802.
Reijers MH, Weverling GJ, Jurriaans S, Wit FW, Weigel HM, Ten Kate RW, Mulder JW, Frissen PH, van Leeuwen R, Reiss P, Schuitemaker H, de Wolf F, Lange JM. Maintenance therapy after quadruple induction therapy in HIV-1 infected individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) study. Lancet. 1998 Jul 18;352(9123):185-90. doi: 10.1016/s0140-6736(98)06193-5.
Kahlert C, Hupfer M, Wagels T, Bueche D, Fierz W, Walker UA, Vernazza PL. Ritonavir boosted indinavir treatment as a simplified maintenance "mono"-therapy for HIV infection. AIDS. 2004 Apr 9;18(6):955-7. doi: 10.1097/00002030-200404090-00017. No abstract available.
Kelly M. Induction-maintenance antiretroviral strategies to reduce long-term toxicity. J HIV Ther. 2003 Feb;8(1):11-4.
Swindells S, DiRienzo AG, Wilkin T, Fletcher CV, Margolis DM, Thal GD, Godfrey C, Bastow B, Ray MG, Wang H, Coombs RW, McKinnon J, Mellors JW; AIDS Clinical Trials Group 5201 Study Team. Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression. JAMA. 2006 Aug 16;296(7):806-14. doi: 10.1001/jama.296.7.806.
McKinnon JE, Mailliard RB, Swindells S, Wilkin TJ, Borowski L, Roper JM, Bastow B, Kearney M, Wiegand A, Mellors JW, Rinaldo CR; A5201 study team. Baseline natural killer and T cell populations correlation with virologic outcome after regimen simplification to atazanavir/ritonavir alone (ACTG 5201). PLoS One. 2014 May 6;9(5):e95524. doi: 10.1371/journal.pone.0095524. eCollection 2014.
Wilkin TJ, McKinnon JE, DiRienzo AG, Mollan K, Fletcher CV, Margolis DM, Bastow B, Thal G, Woodward W, Godfrey C, Wiegand A, Maldarelli F, Palmer S, Coffin JM, Mellors JW, Swindells S. Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy: final 48-week clinical and virologic outcomes. J Infect Dis. 2009 Mar 15;199(6):866-71. doi: 10.1086/597119.
Other Identifiers
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10096
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5201
Identifier Type: -
Identifier Source: secondary_id
A5201
Identifier Type: -
Identifier Source: org_study_id