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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: ATV/r

Study type: Interventional

Funder types: Other

Identifiers

NCT01159223

HIV - NAT 110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 559 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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559 participants in 2 patient groups

1

Experimental group

Description:

ATV/r 200 mg/100 mg OD

Treatment:

Drug: ATV/r

2

Experimental group

Description:

ATV/r 300 mg/100 mg OD

Treatment:

Drug: ATV/r