Clinical Trial: Atazanavir/Ritonavir Maintenance Therapy

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

Long-term side effects, the expense of medications, and the difficulty of taking medications continuously for long periods of time are all problems with complicated anti-HIV drug regimens. The purpose of this study is to determine whether two drugs, atazanavir and ritonavir, will control HIV infection when taken together without any other anti-HIV drugs after 48 weeks of viral suppression.

Condition Treatment or Intervention
HIV Infections
 Drug: Atazanavir
 Drug: Ritonavir

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

Further Study Details: 
Primary Outcomes: Virologic failure, defined as 2 consecutive viral load measurements of 200 copies/ml or greater, at or before Week 30 (24 weeks on ATV/RTV alone)
Expected Total Enrollment:  33

The expense, difficulty, and long-term adverse events associated with sustained adherence to combination antiretroviral therapy emphasize the need for simpler, alternative treatment strategies for HIV infection. Studies have shown that single protease inhibitor (PI) maintenance therapy may provide sufficient virologic suppression while reducing the risk of nucleoside reverse transcriptase inhibitor (NRTI)-associated metabolic complications. This study will determine whether simplified maintenance therapy with ritonavir-boosted atazanavir (ATV/RTV) after 48-week virologic suppression will increase the likelihood of virologic failure.

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • HIV infected
  • 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:

  • Current or prior use of an NNRTI
  • 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
  • Involuntarily incarcerated 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

Location and Contact Information


California
      Stanford University, Stanford,  California,  94305-5107,  United States; Recruiting
Debbie Slamowitz, RN, BSN, ACRN  650-723-2804    dslam@stanford.edu 

      University of California, San Diego Antiviral Research, San Diego,  California,  92103,  United States; Recruiting
Jill Kunkel, R.N.  619-543-8080    jkunkel@ucsd.edu 

Colorado
      Univ. of Colorado Health Sciences Center, Denver, Denver,  Colorado,  80262-3706,  United States; Recruiting
M. Graham Ray, RN, MSN  303-372-5535    graham.ray@uchsc.edu 

Florida
      University of Miami, Miami,  Florida,  33136-1013,  United States; Recruiting
Leslie Thompson, RN, BSN  305-243-3838    lthomps@gate.net 

Hawaii
      University of Hawaii, Honolulu,  Hawaii,  96816-2396,  United States; Recruiting
Debra M. Ogata-Arakaki, RN  808-737-2751    ogataara@hawaii.edu 

Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242-1201,  United States; Recruiting
Julie Katseres, ARNP, MSN, CCRC  (319) 353-8441    katseres.julie@fstrf.org 

Maryland
      University of Maryland, Institute of Human Virology, Baltimore,  Maryland,  21201,  United States; Recruiting
Sandy Zaremba, RN, CCRC  410-706-1476    zaremba@umbi.umd.edu 

Massachusetts
      Brigham and Womens Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Lynn Dumas, RN  617-732-4785    ldumas1@partners.org 

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455-0392,  United States; Recruiting
Christine Fietzer, RN, BSN  612-625-1462    fietz002@umn.edu 

Missouri
      Washington University (St. Louis), St. Louis,  Missouri,  63108-2138,  United States; Recruiting
Michael Klebert, RN-C, MSN  314-454-0058    mklebert@im.wustl.edu 

Nebraska
      Nebraska Health System, Omaha,  Nebraska,  68198-5130,  United States; Recruiting
Frances G. Van Meter, RN, ARNP, MSN  (402) 559-8163    fvanmete@unmc.edu 

New York
      The Cornell Clinical Trials Unit, New York,  New York,  10021,  United States; Recruiting
Valery Hughes, NP  212-746-4393    vah9001@nyp.org 

      Chelsea Clinic, New York,  New York,  10011,  United States; Recruiting
Todd Stroberg, RN  212-746-7198    tstrober@nyp.org 

North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
Cheryl J. Marcus, RN, BSN  919-843-8761    cjm@med.unc.edu 

      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Suzanne Aycock, RN, BSN, CCRC  (919) 684-8216    aycoc001@mc.duke.edu 

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267-0405,  United States; Recruiting
Tammy Powell, RN  513-584-8373    powelltm@email.uc.edu 

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States; Recruiting
Christine Tripoli, BSN, RN  412-647-0771    tripolica@msx.upmc.edu 

Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
Joan Gormley, BSN  401-793-4396    jgormley@lifespan.org 

      Rhode Island Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
Joan Gormley, BSN  401-793-4396    jgormley@lifespan.org 

      Stanley Street Treatment and Resource, Providence,  Rhode Island,  02906,  United States; Recruiting
Joan Gormley, BSN  401-793-4396    jgormley@lifespan.org 

Washington
      University of Washington (Seattle), Seattle,  Washington,  98104,  United States; Recruiting
Jeanne Conley, RN, BSN  206-731-8877    njc@u.washington.edu 

Puerto Rico
      University of Puerto Rico, San Juan,  00936-5067,  Puerto Rico; Recruiting
Sylvia I Davila, BS, MS  (787) 759-9595    sdavila@rcm.upr.edu 

Study chairs or principal investigators

Susan Swindells, MD,  Study Chair,  University of Nebraska   

More Information

Click here for more information about atazanavir

Click here for more information about ritonavir

Haga clic aquí para ver información sobre este ensayo clínico en español.

Publications

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 patients 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.

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.

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.

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. No abstract available.

Kelly M. Induction-maintenance antiretroviral strategies to reduce long-term toxicity. J HIV Ther. 2003 Feb;8(1):11-4.

Study ID Numbers:  ACTG A5201
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  June 4, 2004
ClinicalTrials.gov Identifier:  NCT00084019
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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