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

NCT01159223 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2016-08-18

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Kirby Institute

    collaborator OTHER_GOV

  • National Health Security Office, Thailand

    collaborator OTHER

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159223 on ClinicalTrials.gov