Acquired Immunodeficiency SyndromePhase 4NCT02348177

Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB

A Phase 4 study testing lopinavir with ritonavir in 1:1 ratio and Lopinavir/ritonavir 4:1 in people with Acquired Immunodeficiency Syndrome and Tuberculosis, run by Drugs for Neglected Diseases at 5 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety. Read more about this study

Who is it for?: Ages 2 weeks and older
Conditions the study is for: Acquired Immunodeficiency Syndrome, Tuberculosis
What is being tested?: lopinavir with ritonavir in 1:1 ratio and Lopinavir/ritonavir 4:1
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 5 sitesSouth Africa
Study dates: Jan 2013to Dec 2016
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 2 weeks and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
Weight >3kg ≤15 kg at enrolment
> 42 weeks gestational age
On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
Clinical diagnosis of TB requiring RIF-based therapy
Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.

Who cannot join

For neonates, less than 42 weeks gestation and 14 days old
Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
Anticipation at the start that anti-TB treatment duration will be longer than 9 months
Any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
Children with known malignancies and contraindications to taking LPV/r
Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Africa5 sites

The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch
Cape Town, Western Cape, 7505
Enhancing Care Foundation; Wendworth Hospital
Durban, 4013
Perinatal HIV Research Unit
Johannesburg, 1864
Shandukani Research WRHI
Johannesburg, 2001
Empilweni Services and Research Unit
Johannesburg, 2093

Other trials in South Africa

About this study

Official title: A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.

Read the detailed description

This is a multicentre, open label, non-randomized, prospective, noninferiority study to compare the pharmacokinetics of lopinavir administered with superboosting (LPV/r 1:1) and concurrent RIF treatment or with standard boosting (LPV/r 4:1) without concurrent RIF treatment, and to assess the safety, tolerance, and virological effect of superboosting in HIV-TB co-infected infants and children weighing >3 kg and ≤15 kg.

LPV/r will be administered as the liquid 80/20 mg/mL formulation (4:1 standard boosting ratio). During anti-TB treatment, additional RTV liquid formulation will be provided to deliver a 1:1 superboosting ratio of LPV to RTV. Actual doses for antiretrovirals and anti-TB drugs will be based on the South African (SA) weight band dosing recommendations and provided as per the site standard of care.

Conditions: Acquired Immunodeficiency Syndrome, Tuberculosis
Being tested: lopinavir with ritonavir in 1:1 ratio, Lopinavir/ritonavir 4:1
Keywords: Human immunideficiency virus, Tuberculosis, superboosting, lopinavir/ritonavir 1:1, Pediatric TB/HIV co-infection
Medical subject headings: Acquired Immunodeficiency Syndrome, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lopinavir with ritonavir in 1:1 ratioDrug
Also called Lopinavir/ritonavir, Ritonavir
During co-treatment of rifampicin containing tuberculosis treatment and lopinavir/ritonavir (4:1) based therapy, additional ritonavir is given to make lopinavir/ritonavir 1:1 ratio
Lopinavir/ritonavir 4:1Drug
Also called Lopinavir/ritonavir
This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped

Study groups in NCT02348177
Study group	Role	What they receive
TB/HIV co-infection	Experimental	Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1 Receives: Drug: lopinavir with ritonavir in 1:1 ratio; Drug: Lopinavir/ritonavir 4:1

What is being measured

The primary outcome is the main question the study is designed to answer.

Modelled C0/morning trough
Proportions of children treated with modelled lopinavir morning C0/morning trough <1mg/L at each of the intensive PK evaluations.
Measured: Predose

Secondary outcomes (3)

C0/morning trough
Proportions of children with observed lopinavir morning trough, C0/morning trough <1mg/L at each of the intensive PK evaluations
Measured: Predose
ALT
Safety and tolerability of superboosting focusing on liver functions through clinical and biochemical monitoring.
Measured: baseline, PK1, PK2, PK3
ECG
Potential superboosting cardiac effect monitored by electrocardiogram at the beginning of anti-TB and HIV concomitant therapy
Measured: baseline, 2 weeks after LPV/r 1:1, PK1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2016

First posted28 Jan 2015 (estimated)
Study startJan 2013
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (49)Papers the sponsor has linked to this study.
Other trials for Acquired Immunodeficiency SyndromeStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348177
Sponsor's protocol ID: DNDiHIVPed001
Status last verified: May 2017
First submitted: 3 Dec 2014
Last updated: 11 May 2017
Results posted: No
Data monitoring committee: Yes

Publications

Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F; Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004 Oct 2-8;364(9441):1236-43. doi: 10.1016/S0140-6736(04)17140-7.
PubMed 15464184
Johnson LF, Davies MA, Moultrie H, Sherman GG, Bland RM, Rehle TM, Dorrington RE, Newell ML. The effect of early initiation of antiretroviral treatment in infants on pediatric AIDS mortality in South Africa: a model-based analysis. Pediatr Infect Dis J. 2012 May;31(5):474-80. doi: 10.1097/INF.0b013e3182456ba2.
PubMed 22189531
Marston M, Becquet R, Zaba B, Moulton LH, Gray G, Coovadia H, Essex M, Ekouevi DK, Jackson D, Coutsoudis A, Kilewo C, Leroy V, Wiktor S, Nduati R, Msellati P, Dabis F, Newell ML, Ghys PD. Net survival of perinatally and postnatally HIV-infected children: a pooled analysis of individual data from sub-Saharan Africa. Int J Epidemiol. 2011 Apr;40(2):385-96. doi: 10.1093/ije/dyq255. Epub 2011 Jan 18.
PubMed 21247884
Gurumurthy P, Ramachandran G, Hemanth Kumar AK, Rajasekaran S, Padmapriyadarsini C, Swaminathan S, Bhagavathy S, Venkatesan P, Sekar L, Mahilmaran A, Ravichandran N, Paramesh P. Decreased bioavailability of rifampin and other antituberculosis drugs in patients with advanced human immunodeficiency virus disease. Antimicrob Agents Chemother. 2004 Nov;48(11):4473-5. doi: 10.1128/AAC.48.11.4473-4475.2004.
PubMed 15504887
McIlleron H, Ren Y, Nuttall J, Fairlie L, Rabie H, Cotton M, Eley B, Meyers T, Smith PJ, Merry C, Maartens G. Lopinavir exposure is insufficient in children given double doses of lopinavir/ritonavir during rifampicin-based treatment for tuberculosis. Antivir Ther. 2011;16(3):417-21. doi: 10.3851/IMP1757.
PubMed 21555825
Zanoni BC, Phungula T, Zanoni HM, France H, Feeney ME. Impact of tuberculosis cotreatment on viral suppression rates among HIV-positive children initiating HAART. AIDS. 2011 Jan 2;25(1):49-55. doi: 10.1097/QAD.0b013e32833f9e04.
PubMed 20935555
Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008 Nov 20;359(21):2233-44. doi: 10.1056/NEJMoa0800971.
PubMed 19020325
Reitz C, Coovadia A, Ko S, Meyers T, Strehlau R, Sherman G, Kuhn L, Abrams EJ. Initial response to protease-inhibitor-based antiretroviral therapy among children less than 2 years of age in South Africa: effect of cotreatment for tuberculosis. J Infect Dis. 2010 Apr 15;201(8):1121-31. doi: 10.1086/651454.
PubMed 20214476
Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1082-90. doi: 10.1001/jama.2010.1278.
PubMed 20823434
Saez-Llorens X, Violari A, Deetz CO, Rode RA, Gomez P, Handelsman E, Pelton S, Ramilo O, Cahn P, Chadwick E, Allen U, Arpadi S, Castrejon MM, Heuser RS, Kempf DJ, Bertz RJ, Hsu AF, Bernstein B, Renz CL, Sun E. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2003 Mar;22(3):216-24. doi: 10.1097/01.inf.0000055061.97567.34.
PubMed 12634581
Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC, Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8.
PubMed 17668553
Chadwick EG, Capparelli EV, Yogev R, Pinto JA, Robbins B, Rodman JH, Chen J, Palumbo P, Serchuck L, Smith E, Hughes M; P1030 team. Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results. AIDS. 2008 Jan 11;22(2):249-55. doi: 10.1097/QAD.0b013e3282f2be1d.
PubMed 18097227
Chadwick EG, Pinto J, Yogev R, Alvero CG, Hughes MD, Palumbo P, Robbins B, Hazra R, Serchuck L, Heckman BE, Purdue L, Browning R, Luzuriaga K, Rodman J, Capparelli E; International Maternal Pediatric Adolescent Clinical Trials Group (IMPAACT) P1030 Team. Early initiation of lopinavir/ritonavir in infants less than 6 weeks of age: pharmacokinetics and 24-week safety and efficacy. Pediatr Infect Dis J. 2009 Mar;28(3):215-9. doi: 10.1097/INF.0b013e31818cc053.
PubMed 19209098
Rakhmanina N, van den Anker J, Baghdassarian A, Soldin S, Williams K, Neely MN. Population pharmacokinetics of lopinavir predict suboptimal therapeutic concentrations in treatment-experienced human immunodeficiency virus-infected children. Antimicrob Agents Chemother. 2009 Jun;53(6):2532-8. doi: 10.1128/AAC.01374-08. Epub 2009 Mar 2.
PubMed 19258274
Elsherbiny D, Ren Y, McIlleron H, Maartens G, Simonsson US. Population pharmacokinetics of lopinavir in combination with rifampicin-based antitubercular treatment in HIV-infected South African children. Eur J Clin Pharmacol. 2010 Oct;66(10):1017-23. doi: 10.1007/s00228-010-0847-9. Epub 2010 Jun 16.
PubMed 20552180

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Acquired Immunodeficiency Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.
ClinicalTrials.gov ID: NCT02348177
Acronym / sponsor ID: DNDiHIVPed001
Conditions: Acquired Immunodeficiency Syndrome, Tuberculosis
Keywords: Human immunideficiency virus, Tuberculosis, superboosting, lopinavir/ritonavir 1:1, Pediatric TB/HIV co-infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Drugs for Neglected DiseasesUniversity, hospital or other
Collaborators: University of Cape Town, Medecins Sans Frontieres, Netherlands, French Development Agency, UBS Optimus Foundation
Study start: Jan 2013
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 28 Jan 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TB/HIV co-infection	Experimental	Drug: lopinavir with ritonavir in 1:1 ratio, Drug: Lopinavir/ritonavir 4:1Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1

Who may qualify

Ages: 2 weeks and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
Weight >3kg ≤15 kg at enrolment
> 42 weeks gestational age
On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
Clinical diagnosis of TB requiring RIF-based therapy

Key exclusion criteria (6 listed)

For neonates, less than 42 weeks gestation and 14 days old
Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
Anticipation at the start that anti-TB treatment duration will be longer than 9 months
Any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
Children with known malignancies and contraindications to taking LPV/r

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
lopinavir with ritonavir in 1:1 ratioAlso: Lopinavir/ritonavir, RitonavirDuring co-treatment of rifampicin containing tuberculosis treatment and lopinavir/ritonavir (4:1) based therapy, additional ritonavir is given to make lopinavir/ritonavir 1:1 ratio	Drug	TB/HIV co-infection
Lopinavir/ritonavir 4:1Also: Lopinavir/ritonavirThis is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped	Drug	TB/HIV co-infection

Primary outcome

Modelled C0/morning trough
Time frame: Predose
Proportions of children treated with modelled lopinavir morning C0/morning trough <1mg/L at each of the intensive PK evaluations.

3 secondary outcomes

C0/morning trough
Time frame: Predose
ALT
Time frame: baseline, PK1, PK2, PK3
ECG
Time frame: baseline, 2 weeks after LPV/r 1:1, PK1

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 11 May 2017.
Background: PubMed 15464184Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F; Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004 Oct 2-8;364(9441):1236-43. doi: 10.1016/S0140-6736(04)17140-7.
Background: PubMed 22189531Johnson LF, Davies MA, Moultrie H, Sherman GG, Bland RM, Rehle TM, Dorrington RE, Newell ML. The effect of early initiation of antiretroviral treatment in infants on pediatric AIDS mortality in South Africa: a model-based analysis. Pediatr Infect Dis J. 2012 May;31(5):474-80. doi: 10.1097/INF.0b013e3182456ba2.
Background: PubMed 21247884Marston M, Becquet R, Zaba B, Moulton LH, Gray G, Coovadia H, Essex M, Ekouevi DK, Jackson D, Coutsoudis A, Kilewo C, Leroy V, Wiktor S, Nduati R, Msellati P, Dabis F, Newell ML, Ghys PD. Net survival of perinatally and postnatally HIV-infected children: a pooled analysis of individual data from sub-Saharan Africa. Int J Epidemiol. 2011 Apr;40(2):385-96. doi: 10.1093/ije/dyq255. Epub 2011 Jan 18.
Background: PubMed 15504887Gurumurthy P, Ramachandran G, Hemanth Kumar AK, Rajasekaran S, Padmapriyadarsini C, Swaminathan S, Bhagavathy S, Venkatesan P, Sekar L, Mahilmaran A, Ravichandran N, Paramesh P. Decreased bioavailability of rifampin and other antituberculosis drugs in patients with advanced human immunodeficiency virus disease. Antimicrob Agents Chemother. 2004 Nov;48(11):4473-5. doi: 10.1128/AAC.48.11.4473-4475.2004.
Background: PubMed 21555825McIlleron H, Ren Y, Nuttall J, Fairlie L, Rabie H, Cotton M, Eley B, Meyers T, Smith PJ, Merry C, Maartens G. Lopinavir exposure is insufficient in children given double doses of lopinavir/ritonavir during rifampicin-based treatment for tuberculosis. Antivir Ther. 2011;16(3):417-21. doi: 10.3851/IMP1757.
Background: PubMed 20935555Zanoni BC, Phungula T, Zanoni HM, France H, Feeney ME. Impact of tuberculosis cotreatment on viral suppression rates among HIV-positive children initiating HAART. AIDS. 2011 Jan 2;25(1):49-55. doi: 10.1097/QAD.0b013e32833f9e04.
Background: PubMed 19020325Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008 Nov 20;359(21):2233-44. doi: 10.1056/NEJMoa0800971.
Background: PubMed 20214476Reitz C, Coovadia A, Ko S, Meyers T, Strehlau R, Sherman G, Kuhn L, Abrams EJ. Initial response to protease-inhibitor-based antiretroviral therapy among children less than 2 years of age in South Africa: effect of cotreatment for tuberculosis. J Infect Dis. 2010 Apr 15;201(8):1121-31. doi: 10.1086/651454.
Background: PubMed 20823434Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1082-90. doi: 10.1001/jama.2010.1278.
Background: PubMed 12634581Saez-Llorens X, Violari A, Deetz CO, Rode RA, Gomez P, Handelsman E, Pelton S, Ramilo O, Cahn P, Chadwick E, Allen U, Arpadi S, Castrejon MM, Heuser RS, Kempf DJ, Bertz RJ, Hsu AF, Bernstein B, Renz CL, Sun E. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2003 Mar;22(3):216-24. doi: 10.1097/01.inf.0000055061.97567.34.
Background: PubMed 17668553Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC, Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8.
Background: PubMed 18097227Chadwick EG, Capparelli EV, Yogev R, Pinto JA, Robbins B, Rodman JH, Chen J, Palumbo P, Serchuck L, Smith E, Hughes M; P1030 team. Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results. AIDS. 2008 Jan 11;22(2):249-55. doi: 10.1097/QAD.0b013e3282f2be1d.
World Health Organization. "Dosing instructions for the use of currently available fixed-dose combination TB medicines for children."Link provided by the sponsor.

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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.

Mark Cotton, Professor principal investigator

University of Stellenbosch

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Africa. 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?

Modelled C0/morning trough (time frame: Predose). 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 NCT02348177, which also lists 49 linked publications.

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 11 May 2017.