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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: ATV/r

• Registration Number: NCT01159223
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Timeline

• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Study Start: 2011-05
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ATV/r	ATV/r 200 mg/100 mg OD
2	ATV/r	ATV/r 300 mg/100 mg OD

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Bamrasnaradura Infectious Diseases Institute; 🇹🇭 Nonthaburi, Thailand

BMA Medical College and Vajira Hospital; 🇹🇭 Bangkok, Thailand

Taksin hospital; 🇹🇭 Bangkok, Thailand

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

HIV-NAT, Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

ChonBuri Hospital; 🇹🇭 ChonBuri, Thailand

Sanpathong Hospital; 🇹🇭 Sanpathong, Chiang Mai, Thailand

Chiang Rai Regional Hospital; 🇹🇭 Chiang Rai, Thailand

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand