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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was  Recruiting
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: March 22, 2012
Last verified: March 2012

June 4, 2010
March 22, 2012
May 2011
December 2012   (final data collection date for primary outcome measure)
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%
viral load at week 48 between 2 groups [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
viral load at week 48 between 2 groups
Complete list of historical versions of study NCT01159223 on ClinicalTrials.gov Archive Site
  • 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
  • CD4 change over time until week 48 between 2 groups [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    CD4 change over time until week 48 between 2 groups
  • liver function test, bilirubin, kidney function test over time between 2 groups [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    liver function test, bilirubin, kidney function test over time between 2 groups
  • incidence of AE between 2 groups [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    incidence of AE between 2 groups
  • ATV plasma concentration incidence of AE between 2 groups [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    ATV plasma concentration incidence of AE between 2 groups
Not Provided
Not Provided
 
Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
HIV Infections
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: 1
    ATV/r 200 mg/100 mg OD
    Intervention: Drug: ATV/r
  • Experimental: 2
    ATV/r 300 mg/100 mg OD
    Intervention: Drug: ATV/r
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kiat Ruxrungtham, MD 662-652-3040 rkiat@chula.ac.th
Contact: Anchalee Avihingsanon, MD 662-652-3040 ext 107 anchalee.a@hivnat.org
Thailand
 
NCT01159223
HIV - NAT 110
Yes
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • Kirby Institute
  • National Health Security Office, Thailand
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP