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

August 17, 2016 updated by: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

559

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre
      • Bangkok, Thailand
        • BMA Medical College and Vajira Hospital
      • Bangkok, Thailand
        • Taksin Hospital
      • Chiang Rai, Thailand
        • Chiang Rai Regional Hospital
      • ChonBuri, Thailand
        • Chonburi hospital
      • Khon Kaen, Thailand
        • Khon Kaen hospital
      • Khon Kaen, Thailand
        • Khon Kaen University
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Infectious Diseases Institute
    • Chiang Mai
      • Sanpathong, Chiang Mai, Thailand
        • Sanpathong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
noninferiority
Time Frame: Dec. 2013
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%
Dec. 2013

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
viral load
Time Frame: DEc. 2013
A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL
DEc. 2013
serious adverse events
Time Frame: Dec. 2013
Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events
Dec. 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Kirby Institute
National Health Security Office, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (ESTIMATE)

July 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV - NAT 110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol available at www.hivnat.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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