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NCT01159223
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
Phase 4 trial testing ATV/r in HIV Infections in 559 participants. Completed in 1 June 2015.
1 December 2014
Quick facts
| Lead sponsor | The HIV Netherlands Australia Thailand Research Collaboration |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 559 |
| Start date | 1 May 2011 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 June 2015 |
| Sites | 10 locations across Thailand |
Drugs / interventions tested
- ATV/r — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration — full company profile →
Who can join
18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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%
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial.
Bunupuradah T, Kiertiburanakul S, Avihingsanon A, Chetchotisakd P, et al · · 2016 · cited 18× · PMID 27470026 · DOI 10.1016/s2352-3018(16)30010-8
Verify or expand the search:
- PubMed search for NCT01159223
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ATV/r
Trials testing the same drug.
- NCT01903031 — Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART · Phase 2 · completed
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
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- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
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Other The HIV Netherlands Australia Thailand Research Collaboration trials
Trials by the same sponsor.
- NCT04552015 — Microneedles for Diagnosis of LTBI · NA · terminated
- NCT03731559 — Efficacy, Safety and Pharmacokinetics of DTG with RIF · Phase 2 · recruiting
- NCT03835832 — Self-Assessment Tuberculin Skin Test · completed
- NCT03727152 — Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolu · Phase 3 · completed
- NCT03037151 — Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01159223 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The HIV Netherlands Australia Thailand Research Collaboration
- Last refreshed: 17 August 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01159223.
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