Atazanavir/Ritonavir Maintenance Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00084019
First received: June 4, 2004
Last updated: June 2, 2014
Last verified: June 2014
  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 (ATV) and ritonavir (RTV), will control HIV infection when taken together without any other anti-HIV drugs after 48 weeks of viral suppression.

Hypothesis: Simplified maintenance therapy with ATV and RTV alone after virologic suppression does not markedly increase the risk of virologic failure.


Condition Intervention
HIV Infections
Drug: Atazanavir
Drug: Ritonavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • Grade 3 and 4 laboratory abnormalities and signs and symptoms
  • time to treatment discontinuation because of toxicity or intolerance
  • virologic failure at or before Week 54
  • viral load determined by modified ultrasensitive RT-PCR assay
  • minor PI variants at virologic failure
  • total cholesterol, high-density lipoprotein (HDL) cholesterol, calculated low-density lipoprotein (LDL) cholesterol, and triglycerides
  • CD4 cell count and percentages at Weeks 30 and 54
  • self-reported adherence scores
  • plasma drug levels characterized by Cmin and AUC
  • detectable viral load in the genital compartment at Week 30

Enrollment: 36
Study Start Date: July 2004
Study Completion Date: May 2006
Detailed Description:

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. However, it is not known whether ritonavir-boosted atazanavir (ATV/RTV) maintenance therapy would be effective in controlling HIV replication in the genital compartments and whether viral load testing by blood collection would be effective in detecting elevated levels of HIV in the genital compartments. This study will determine whether simplified maintenance therapy with 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. At Week 30, viral load will be measured in the genital secretions of both male and female study participants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084019

Locations
United States, California
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States, 94304-5350
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
United States, Iowa
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
United States, Nebraska
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States, 68198-9500
United States, New York
Weill Cornell Chelsea CRS
New York, New York, United States, 10011
United States, North Carolina
Chapel Hill CRS
Chapel Hill, North Carolina, United States, 27599
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati CRS
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Dallas VAMC
Dallas, Texas, United States, 75216
Puerto Rico
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Investigators
Study Chair: Susan Swindells, MD University of Nebraska
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00084019     History of Changes
Other Study ID Numbers: A5201, 10096, ACTG A5201
Study First Received: June 4, 2004
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014