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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01159223

Enrollment

559

Registered

2010-07-09

Start date

2011-05-31

Completion date

2015-06-30

Last updated

2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

atazanavir / ritonavir, low dose, noninferiority, safety and efficacy, efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults

Brief summary

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.

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.

Interventions

DRUGATV/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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
noninferiority	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%

Secondary

Measure	Time frame	Description
viral load	DEc. 2013	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	Dec. 2013	Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026