HIV InfectionsPhase 4NCT01159223
Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)
A Phase 4 study testing ATV/r in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- ATV/r
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 10 sitesThailand
- Study dates
- May 2011to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected adults aged more than or equal to 18 years
- Received ritonavir boosted PI-based HAART for >3 months prior screening visit
- History of HIV RNA < 50 copies/ml within 12 months prior to screening visit
- HIV-RNA < 50 copies/ml at screening visit
- Signed written informed consent
Who cannot join
- Active AIDS-defining disease or active opportunistic infection
- History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
- Pregnancy or lactation at screening visit
- Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
- Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
- ALT ≥200 IU/L at screening visit
- Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula at screening visit
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Thailand10 sites
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330
BMA Medical College and Vajira Hospital
Bangkok
Ramathibodi Hospital
Bangkok
Taksin hospital
Bangkok
Chiang Rai Regional Hospital
Chiang Rai, Changwat Chiang Rai
ChonBuri Hospital
Chon Buri, Changwat Chon Buri
Khon Kaen University
Khon Kaen, Changwat Khon Kaen
Khon Kaen Hospital
Khon Kaen
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, 11000
Sanpathong Hospital
Sanpathong, Chiang Mai
About this study
Official title: 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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- ATV/r
- Keywords
- atazanavir / ritonavir, low dose, noninferiority, safety and efficacy, efficacy and safety of lower dose atazanavir/ritonavir in suppressed HIV-infected adults
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATV/rDrug
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ATV/r 200 mg/100 mg OD Receives: Drug: ATV/r |
| 2 | Experimental | ATV/r 300 mg/100 mg OD Receives: Drug: ATV/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
noninferiority
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%
Measured: Dec. 2013
Secondary outcomes (2)
viral load
A secondary efficacy analysis will explore the impact of changing the lower limit of detection of viral load to <50 copies/mL
Measured: DEc. 2013
serious adverse events
Changes in HDL, LDL, cholesterol, triglycerides and bilirubin, or having grade 3 and 4 laboratory adverse events
Measured: Dec. 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Kirby Institute, National Health Security Office, Thailand
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159223
- Sponsor's protocol ID
- HIV - NAT 110
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2010
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: study protocol available at www.hivnat.org
Publications
Bunupuradah T, Kiertiburanakul S, Avihingsanon A, Chetchotisakd P, Techapornroong M, Leerattanapetch N, Kantipong P, Bowonwatanuwong C, Banchongkit S, Klinbuayaem V, Mekviwattanawong S, Nimitvilai S, Jirajariyavej S, Prasithsirikul W, Munsakul W, Bhakeecheep S, Chaivooth S, Phanuphak P, Cooper DA, Apornpong T, Kerr SJ, Emery S, Ruxrungtham K; LASA Study Group. Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial. Lancet HIV. 2016 Aug;3(8):e343-e350. doi: 10.1016/S2352-3018(16)30010-8. Epub 2016 May 24.
PubMed 27470026
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01159223
- Acronym / sponsor ID
- HIV - NAT 110
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Kirby Institute, National Health Security Office, Thailand
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ATV/rATV/r 200 mg/100 mg OD |
| 2 | Experimental | Drug: ATV/rATV/r 300 mg/100 mg OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infected adults aged more than or equal to 18 years
- Received ritonavir boosted PI-based HAART for >3 months prior screening visit
- History of HIV RNA < 50 copies/ml within 12 months prior to screening visit
- HIV-RNA < 50 copies/ml at screening visit
- Signed written informed consent
Key exclusion criteria (8 listed)
- Active AIDS-defining disease or active opportunistic infection
- History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
- Pregnancy or lactation at screening visit
- Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
- Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATV/rAll 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 | Drug | 1, 2 |
Primary outcome
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%
2 secondary outcomes
viral load
Time frame: DEc. 2013
serious adverse events
Time frame: Dec. 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Results publication: PubMed 27470026Bunupuradah T, Kiertiburanakul S, Avihingsanon A, Chetchotisakd P, Techapornroong M, Leerattanapetch N, Kantipong P, Bowonwatanuwong C, Banchongkit S, Klinbuayaem V, Mekviwattanawong S, Nimitvilai S, Jirajariyavej S, Prasithsirikul W, Munsakul W, Bhakeecheep S, Chaivooth S, Phanuphak P, Cooper DA, Apornpong T, Kerr SJ, Emery S, Ruxrungtham K; LASA Study Group. Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial. Lancet HIV. 2016 Aug;3(8):e343-e350. doi: 10.1016/S2352-3018(16)30010-8. Epub 2016 May 24.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. study protocol available at www.hivnat.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, MD principal investigator
HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ATV/r in people with HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
noninferiority (time frame: Dec. 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.