HIVPhase 3PRINCE2NCT01335698
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
A Phase 3 study testing Atazanavir Sulphate and Ritonavir in people with HIV, run by Bristol-Myers Squibb at 32 sites in 11 countries.
Trial summary
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years. Read more about this study
- Who is it for?
- Ages 3 months to 11 years
- Conditions the study is for
- HIV
- What is being tested?
- Atazanavir Sulphate and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 32 sitesin 11 countries
- Study dates
- 27 May 2011to 22 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed HIV-1 infection diagnosed by protocol criteria
- Screening HIV RNA level ≥1000 copies/mL
- ≥3 months to <11 years of age at time of first treatment
- Antiretroviral-naive or -experienced
- At screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved for pediatric use at the local country.
- Antiretroviral-experienced patients must also have documented phenotypic sensitivity at screening to atazanavir (Fold Change in susceptibility <2.2) and to at least 2 NRTIs that are approved in their country
Who cannot join
- Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures
- Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications
- Cardiac rhythm abnormalities
- Need for tenofovir
- Weight <5 or ≥35kg
- >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels
- Coinfection with either hepatitis B or C virus
- Any active Centers for Disease Control and Prevention Category C clinical condition
Trial locations and contacts
32 sites in 11 countries.
32 sites in 11 countries
South Africa8 sites
Local Institution
Benoni, Gauteng, 1501
Local Institution
Bloemfontein, Free State, 9301
Local Institution
Coronationville, Gauteng, 2092
Local Institution
Parrow Valley, Western Cape, 7505
Local Institution
Port Elizabeth, Eastern Cape, 6001
Local Institution
Port Elizabeth, Eastern Cape, 6014
Local Institution
Pretoria, Gauteng, 0001
Local Institution
Soweto, Gauteng, 2001
Mexico6 sites
Local Institution
Df, Mexico City, 06720
Local Institution
Guadalajara, Jalisco, 44160
Local Institution
Guadalajara, Jalisco, 44280
Local Institution
Mérida, Yucatán, 97000
Local Institution
Oaxaca City, 71256
Local Institution
Puebla City, 72000
Brazil4 sites
Local Institution
Porto Alegre, Rio Grande do Sul, 90020-090
Local Institution
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution
Recife, Pernambuco, 50070-500
Local Institution
Ribeirão Preto, São Paulo, 14049-900
Russia3 sites
Local Institution
Saint Petersburg, 189635
Local Institution
Saint Petersburg, 198103
Local Institution
Smolensk, 214006
United States2 sites
SUNY Upstate Medical University
Syracuse, New York, 13210
Children'S National Medical Center
Washington D.C., District of Columbia, 20010
Argentina2 sites
Local Institution
Buenos Aires, Bs As, Buenos Aires, 1141
Local Institution
Bunos Aires, Buenos Aires, 1425
Chile2 sites
Local Institution
Santiago, Santiago Metropolitan, 8380418
Local Institution
Santiago, Santiago Metropolitan
United Kingdom1 site
Local Institution
Birmingham, WEST Midlands, B9 5ST
About this study
Official title: A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir SulphateDrug
Also called Reyataz, BMS-232632
RitonavirDrug
Also called Norvir
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Atazanavir + Ritonavir | Experimental | Participants received atazanavir powder orally (dosed by weight: 5 to <10 kg=150 mg, 5 to <10 kg=200 mg, 10 to <15 kg=200 mg, 15 to <25 kg=250 mg, 25 to <35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to <25 kg=80 mg, 25 to <35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to <35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to <35 kg=100 mg) Receives: Drug: Atazanavir Sulphate; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
Measured: Day one to week 300 (approximately 22-Jan-2018)
Number of Participants Who Experienced a SAE on ATV Powder
SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization
Measured: Day one to week 300 (approximately 22-Jan-2018)
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.
Measured: Day one to week 300 (approximately 22-Jan-2018)
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.
Measured: Day one to week 300 (approximately 22-Jan-2018)
Secondary outcomes (8)
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.
Measured: Day 1 of treatment to weeks 24 and 48
Mean Change From Baseline in HIV RNA on ATV Powder
Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values
Measured: Baseline to Weeks 24 and 48
Mean Change From Baseline in CD4 Percent on ATV Powder
Change in CD4 percent using observed values
Measured: Baseline to Weeks 24 and 48
CD4 Cell Count Changes From Baseline on ATV Powder
CD4 cell count change from baseline using observed values
Measured: Baseline to Weeks 24 and 48
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor
Measured: Baseline through Week 48
Maximum Observed Plasma Concentration (Cmax)
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax
Measured: Baseline to Week 2
Minimum Plasma Concentration (Cmin)
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin
Measured: Baseline to Week 2
Area Under the Concentration-Time Curve [AUC(TAU)]
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC
Measured: Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study start27 May 2011
- Primary completion10 Sep 2014
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335698
- Sponsor's protocol ID
- AI424-451
- Other IDs
- 2010-024537-23
- Acronym
- PRINCE2
- Status last verified
- Oct 2018
- First submitted
- 13 Apr 2011
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)
- ClinicalTrials.gov ID
- NCT01335698
- Acronym / sponsor ID
- PRINCE2 / AI424-451
- Conditions
- HIV
- Keywords
- Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 May 2011 (actual)
- Primary completion
- 10 Sep 2014 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Atazanavir + Ritonavir | Experimental | Drug: Atazanavir Sulphate, Drug: RitonavirParticipants received atazanavir powder orally (dosed by weight: 5 to <10 kg=150 mg, 5 to <10 kg=200 mg, 10 to <15 kg=200 mg, 15 to <25 kg=250 mg, 25 to <35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to <25 kg=80 mg, 25 to <35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to <35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to <35 kg=100 mg) |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Confirmed HIV-1 infection diagnosed by protocol criteria
- Screening HIV RNA level ≥1000 copies/mL
- ≥3 months to <11 years of age at time of first treatment
- Antiretroviral-naive or -experienced
- At screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved for pediatric use at the local country.
Key exclusion criteria (8 listed)
- Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures
- Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications
- Cardiac rhythm abnormalities
- Need for tenofovir
- Weight <5 or ≥35kg
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 |
|---|---|---|
| Atazanavir SulphateAlso: Reyataz, BMS-232632 | Drug | Stage 1: Atazanavir + Ritonavir |
| RitonavirAlso: Norvir | Drug | Stage 1: Atazanavir + Ritonavir |
Primary outcome
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Time frame: Day one to week 300 (approximately 22-Jan-2018)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
Number of Participants Who Experienced a SAE on ATV Powder
Time frame: Day one to week 300 (approximately 22-Jan-2018)
SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Time frame: Day one to week 300 (approximately 22-Jan-2018)
The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Time frame: Day one to week 300 (approximately 22-Jan-2018)
Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.
8 secondary outcomes
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Time frame: Day 1 of treatment to weeks 24 and 48
Mean Change From Baseline in HIV RNA on ATV Powder
Time frame: Baseline to Weeks 24 and 48
Mean Change From Baseline in CD4 Percent on ATV Powder
Time frame: Baseline to Weeks 24 and 48
CD4 Cell Count Changes From Baseline on ATV Powder
Time frame: Baseline to Weeks 24 and 48
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Time frame: Baseline through Week 48
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline to Week 2
Minimum Plasma Concentration (Cmin)
Time frame: Baseline to Week 2
Area Under the Concentration-Time Curve [AUC(TAU)]
Time frame: Baseline to Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
32 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanavir Sulphate and Ritonavir in people with HIV, run by Bristol-Myers Squibb at 32 sites in 11 countries.
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 6 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in South Africa, Mexico, Brazil, Russia, United States and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder (time frame: Day one to week 300 (approximately 22-Jan-2018)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2018.