Atazanavir/Ritonavir Maintenance Therapy - Article
Clinical Trial: Atazanavir/Ritonavir Maintenance Therapy
This study is currently recruiting patients.
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 |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- 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
Stanford University, Stanford, California, 94305-5107, United States; Recruiting
University of California, San Diego Antiviral Research, San Diego, California, 92103, United States; Recruiting
Univ. of Colorado Health Sciences Center, Denver, Denver, Colorado, 80262-3706, United States; Recruiting
University of Miami, Miami, Florida, 33136-1013, United States; Recruiting
University of Hawaii, Honolulu, Hawaii, 96816-2396, United States; Recruiting
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242-1201, United States; Recruiting
University of Maryland, Institute of Human Virology, Baltimore, Maryland, 21201, United States; Recruiting
Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States; Recruiting
University of Minnesota, Minneapolis, Minnesota, 55455-0392, United States; Recruiting
Washington University (St. Louis), St. Louis, Missouri, 63108-2138, United States; Recruiting
Nebraska Health System, Omaha, Nebraska, 68198-5130, United States; Recruiting
The Cornell Clinical Trials Unit, New York, New York, 10021, United States; Recruiting
Chelsea Clinic, New York, New York, 10011, United States; Recruiting
University of North Carolina, Chapel Hill, North Carolina, 27514, United States; Recruiting
Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
University of Cincinnati, Cincinnati, Ohio, 45267-0405, United States; Recruiting
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213-2582, United States; Recruiting
The Miriam Hospital, Providence, Rhode Island, 02906, United States; Recruiting
Rhode Island Hospital, Providence, Rhode Island, 02906, United States; Recruiting
Stanley Street Treatment and Resource, Providence, Rhode Island, 02906, United States; Recruiting
University of Washington (Seattle), Seattle, Washington, 98104, United States; Recruiting
University of Puerto Rico, San Juan, 00936-5067, Puerto Rico; Recruiting
Susan Swindells, MD, Study Chair, University of Nebraska
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.
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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
Cache Date: April 9, 2005
- Birds, Infections from (Centers for Disease Control and Prevention)