Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kirby Institute
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01159223
First received: June 4, 2010
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg given daily in Thai patients in combination with 2NRTIs.


Condition Intervention Phase
HIV Infections
Drug: ATV/r
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study to Compare the Efficacy and Safety of Lower Dose Atazanavir /Ritonavir (ATV/r 200/100 OD) Versus Standard Dose (ATV/r 300/100 mg OD) in Combination With 2NRTIs in Well Virology Suppressed HIV-infected Adults

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • noninferiority [ Time Frame: Dec. 2013 ] [ Designated as safety issue: Yes ]
    ATV/r 200/100 mg will be judged to be non-inferior to ATV 300/100mg if the lower limit of the 95% confidence interval for the difference in proportion of patients with virological response between the two groups does not exceed -10%


Secondary Outcome Measures:
  • viral load [ Time Frame: DEc. 2013 ] [ Designated as safety issue: Yes ]
    A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL

  • serious adverse events [ Time Frame: Dec. 2013 ] [ Designated as safety issue: Yes ]
    Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events


Enrollment: 559
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ATV/r 200 mg/100 mg OD
Drug: ATV/r
All participants will be randomized to take ATV/r 200 mg/100 mg OD or ATV/r 300/100 mg OD. NRTIs background regimens will remain unchanged if possible. NRTIs background may include zidovudine/lamivudine, zidovudine plus ddI, ddI plus lamivudine, tenofovir plus lamivudine, tenofovir/emtricitabine, zidovudine plus tenofovir. NRTI backbone could be switched or modified due to toxicity or intolerance
Experimental: 2
ATV/r 300 mg/100 mg OD
Drug: ATV/r
All participants will be randomized to take ATV/r 200 mg/100 mg OD or ATV/r 300/100 mg OD. NRTIs background regimens will remain unchanged if possible. NRTIs background may include zidovudine/lamivudine, zidovudine plus ddI, ddI plus lamivudine, tenofovir plus lamivudine, tenofovir/emtricitabine, zidovudine plus tenofovir. NRTI backbone could be switched or modified due to toxicity or intolerance

Detailed Description:

To demonstrate non-inferiority of treatment with atazanavir/ritonavir (ATV/r) 200/100 mg once daily (OD) compared to the control group (ATV/r 300/100 mg OD) in regards to the proportion of virologic responders (plasma HIV RNA < 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV infected adults aged more than or equal to 18 years
  2. Received ritonavir boosted PI-based HAART for >3 months prior screening visit
  3. History of HIV RNA < 50 copies/ml within 12 months prior to screening visit
  4. HIV-RNA < 50 copies/ml at screening visit
  5. Signed written informed consent

Exclusion Criteria:

  1. Active AIDS-defining disease or active opportunistic infection
  2. History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
  3. Pregnancy or lactation at screening visit
  4. Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
  5. Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
  6. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
  7. ALT ≥200 IU/L at screening visit
  8. Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula at screening visit
  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: NCT01159223

Locations
Thailand
Sanpathong Hospital
Sanpathong, Chiang Mai, Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Taksin hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
BMA Medical College and Vajira Hospital
Bangkok, Thailand
Chiang Rai Regional Hospital
Chiang Rai, Thailand
ChonBuri Hospital
ChonBuri, Thailand
Khon Kaen Hospital
Khon Kaen, Thailand
Khon Kaen University
Khon Kaen, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Kirby Institute
National Health Security Office, Thailand
Investigators
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
  More Information

Additional Information:
No publications provided

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01159223     History of Changes
Other Study ID Numbers: HIV - NAT 110
Study First Received: June 4, 2010
Last Updated: August 6, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
atazanavir / ritonavir
low dose
noninferiority
safety and efficacy
efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults

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

ClinicalTrials.gov processed this record on October 22, 2014