HIV-1Phase 2NCT00355524
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
A Phase 2 study testing TMC114 and Ritonavir in people with HIV-1 and HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 22 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- HIV-1, HIV Infections
- What is being tested?
- TMC114 and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 22 sitesin 8 countries
- Study dates
- Jun 2006to Mar 2011
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants with documented human immunodeficiency virus (HIV)-1 infection failing their current antiretroviral therapy
- Body weight for Part 1: greater than or equal to 20 Kilogram (kg) but less than 50 kg and body weight for Part 2: greater than or equal to 50 kg and from greater than or equal to 20 but less than 50 kg after pediatric dose selection
- Able to swallow the TMC114 tablet formulations, the ritonavir capsule formulation, and to tolerate the ritonavir liquid formulation
- Stable cluster of differentiation 4 (CD4+) percentage; that is no more than 5 percent decrease in CD4+ percentage between the Screening visit and the last available CD4+ measurement
- Female participants who are sexually active and able to become pregnant must use a safe and effective birth control method
Who cannot join
- For Part 1: Use of the non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) efavirenz as part of the current regimen was not allowed and for Part 2: Use of efavirenz as part of the current regimen was allowed and use of any antiretroviral and non-antiretroviral investigational agents within 30 days prior to screening
- Presence of any currently active acquired immune deficiency syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age)
- Pregnant or breastfeeding female participants
- Previous allergy or hypersensitivity to any excipients of the investigational medication (TMC114) or ritonavir
- Any Grade 3 or 4 toxicity as defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
United States7 sites
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Washington D.C., District of Columbia
Study site
Worcester, Massachusetts
Brazil4 sites
Study site
Belo Horizonte
Study site
Nova Iguaçu
Study site
Ribeirão Preto
Study site
Rio de Janeiro
South Africa3 sites
Study site
Cape Town Cape
Study site
Durban
Study site
Johannesburg Gauteng
About this study
Official title: A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.
Read the detailed description
This is an open-label (all people know the identity of the intervention) and randomized (study drug assigned by chance) study to evaluate pharmacokinetics, safety, tolerability, efficacy, antiviral activity, immunology and resistance characteristics of TMC114 with ritonavir in treatment-experienced, HIV-1 infected children and adolescent participants. The study consists of 3 periods: Screening period (maximum 4 weeks); Treatment period (maximum 48 weeks); and Follow-up period (4 weeks). The Treatment period consists of two parts: Part-1 for pediatric dose selection and Part-2 for the recommendation of pediatric or adult dose. Part-1 was further divided into two groups: Group A with adult equivalent dose of TMC114 with ritonavir twice daily and Group B with 20-33 percent higher dose of TMC114 with ritonavir twice daily. The recommended dose will be selected based on short-term safety, tolerability, antiviral activity and pharmacokinetics at Week 2. Once selected, all Part-1 participants who will not be on the selected dose will be switched to the selected dose at their next visit and will continue the study up to 48 weeks in Part-2. Participants with less than or equal to 18 years at Week 48 visit, and continued to benefit from treatment with TMC114 and will be living in a country where TMC114 pediatric use is not yet part of the label, will have the opportunity to roll-over to the extension phase where they will continue to receive TMC114/ritonavir until the participant became 18 years and TMC114 will be available through the local Health Care Systems or until TMC114 is indicated for use in pediatrics. Efficacy will primarily be evaluated by virologic response. Participants' safety will be monitored throughout the study.
- Conditions
- HIV-1, HIV Infections
- Being tested
- TMC114, Ritonavir
- Keywords
- HIV-1, Darunavir, Ritonavir, TMC114
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC114Drug
Also called Darunavir
TMC114 will be administered as oral tablets (75 milligram [mg] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks.
RitonavirDrug
Ritonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A with >= 20 kg to < 30 kg body weight | Experimental | 300 milligram (mg) of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Group A with >= 30 kg to < 40 kg body weight | Experimental | 300 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Group A with >= 40 kg to < 50 kg body weight | Experimental | 450 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Group B with >= 20 kg to < 30 kg body weight | Experimental | 375 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Group B with >= 30 kg to < 40 kg body weight | Experimental | 450 mg of TMC114 tablet with 60 mg (which is equivalent to 0.75 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Group B with >= 40 kg to < 50 kg body weight | Experimental | 600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
| Participants with >= 50 kg body weight | Experimental | 600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. Receives: Drug: TMC114; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 1
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Measured: Week 2
Predose Plasma Concentration (C0) - Part 1
The C0 is the predose plasma concentration.
Measured: Week 2
Maximum Observed Plasma Concentration (Cmax) - Part 1
The Cmax is the maximum observed plasma concentration.
Measured: Week 2
Recommended Dose of TMC114 per Body Weight
The recommended dose of TMC114 will be determined in participants with a body weight: greater than and equal to 20 Kilogram (kg) to less than 30 kg; greater than and equal to 30 kg to less than 40 kg; and greater than 40 kg.
Measured: Week 2
Change From Baseline in Plasma Viral Load at Week 2 - Part 1
Plasma viral load levels will be determined using Roche amplicor human immunodeficiency virus (HIV)-1 monitor test (Version 1.5).
Measured: Baseline and Week 2
Change From Baseline in Plasma Viral Load at Week 24- Part 2
Plasma viral load levels will be determined using Roche amplicor HIV-1 monitor test (Version 1.5).
Measured: Baseline and Week 24
Number of Participants With Adverse Events
Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
Measured: Week 2
Number of Participants With Adverse Events
Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
Measured: Week 24
Secondary outcomes (6)
Change From Baseline in Plasma Viral Load at Week 48 - Part 2
Plasma viral load levels will be determined using Roche amplicor HIV-1 monitor test (Version 1.5).
Measured: Baseline and Week 48
Change from Baseline in Cluster of Differentiation 4 (CD4+) cell count - Part 2
The immunologic change will be determined by changes in CD4+ cell count.
Measured: Baseline and Week 48
Number of Participants With Resistance - Part 2
Resistance will be determined by viral phenotype and genotype determinations, which will be performed by Virco BVBA, by means of the antivirogram and Virco type HIV-1 respectively. Resistance determinations will only be generated if the viral load is greater than 1000 HIV-1 RNA copies/milliliter.
Measured: Week 48
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 2
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Measured: Week 48
Predose Plasma Concentration (C0) - Part 2
The C0 is the predose plasma concentration.
Measured: Week 48
Oral Clearance (CL/F) - Part 2
The CL/F is the oral clearance; that is clearance based on oral bioavailability.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionMar 2011
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-1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Limited, Ireland Clinical Trial, Study director, Tibotec Pharmaceuticals, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355524
- Sponsor's protocol ID
- CR002797
- Other IDs
- TMC114-C212
- Status last verified
- Jul 2013
- First submitted
- 21 Jul 2006
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blanche S, Bologna R, Cahn P, Rugina S, Flynn P, Fortuny C, Vis P, Sekar V, van Baelen B, Dierynck I, Spinosa-Guzman S. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009 Sep 24;23(15):2005-13. doi: 10.1097/QAD.0b013e328330abaa.
PubMed 19724191
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents
- ClinicalTrials.gov ID
- NCT00355524
- Acronym / sponsor ID
- CR002797
- Conditions
- HIV-1, HIV Infections
- Keywords
- HIV-1, Darunavir, Ritonavir, TMC114
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Jul 2006 (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.
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.
Detailed description
This is an open-label (all people know the identity of the intervention) and randomized (study drug assigned by chance) study to evaluate pharmacokinetics, safety, tolerability, efficacy, antiviral activity, immunology and resistance characteristics of TMC114 with ritonavir in treatment-experienced, HIV-1 infected children and adolescent participants. The study consists of 3 periods: Screening period (maximum 4 weeks); Treatment period (maximum 48 weeks); and Follow-up period (4 weeks). The Treatment period consists of two parts: Part-1 for pediatric dose selection and Part-2 for the recommendation of pediatric or adult dose. Part-1 was further divided into two groups: Group A with adult equivalent dose of TMC114 with ritonavir twice daily and Group B with 20-33 percent higher dose of TMC114 with ritonavir twice daily. The recommended dose will be selected based on short-term safety, tolerability, antiviral activity and pharmacokinetics at Week 2. Once selected, all Part-1 participants who will not be on the selected dose will be switched to the selected dose at their next visit and will continue the study up to 48 weeks in Part-2. Participants with less than or equal to 18 years at Week 48 visit, and continued to benefit from treatment with TMC114 and will be living in a country where TMC114 pediatric use is not yet part of the label, will have the opportunity to roll-over to the extension phase where they will continue to receive TMC114/ritonavir until the participant became 18 years and TMC114 will be available through the local Health Care Systems or until TMC114 is indicated for use in pediatrics. Efficacy will primarily be evaluated by virologic response. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group A with >= 20 kg to < 30 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir300 milligram (mg) of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily. |
| Group A with >= 30 kg to < 40 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir300 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily. |
| Group A with >= 40 kg to < 50 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir450 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. |
| Group B with >= 20 kg to < 30 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir375 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily. |
| Group B with >= 30 kg to < 40 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir450 mg of TMC114 tablet with 60 mg (which is equivalent to 0.75 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily. |
| Group B with >= 40 kg to < 50 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. |
| Participants with >= 50 kg body weight | Experimental | Drug: TMC114, Drug: Ritonavir600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants with documented human immunodeficiency virus (HIV)-1 infection failing their current antiretroviral therapy
- Body weight for Part 1: greater than or equal to 20 Kilogram (kg) but less than 50 kg and body weight for Part 2: greater than or equal to 50 kg and from greater than or equal to 20 but less than 50 kg after pediatric dose selection
- Able to swallow the TMC114 tablet formulations, the ritonavir capsule formulation, and to tolerate the ritonavir liquid formulation
- Stable cluster of differentiation 4 (CD4+) percentage; that is no more than 5 percent decrease in CD4+ percentage between the Screening visit and the last available CD4+ measurement
- Female participants who are sexually active and able to become pregnant must use a safe and effective birth control method
Key exclusion criteria (5 listed)
- For Part 1: Use of the non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) efavirenz as part of the current regimen was not allowed and for Part 2: Use of efavirenz as part of the current regimen was allowed and use of any antiretroviral and non-antiretroviral investigational agents within 30 days prior to screening
- Presence of any currently active acquired immune deficiency syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age)
- Pregnant or breastfeeding female participants
- Previous allergy or hypersensitivity to any excipients of the investigational medication (TMC114) or ritonavir
- Any Grade 3 or 4 toxicity as defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale
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 |
|---|---|---|
| TMC114Also: DarunavirTMC114 will be administered as oral tablets (75 milligram [mg] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks. | Drug | Group A with >= 20 kg to < 30 kg body weight, Group A with >= 30 kg to < 40 kg body weight, Group A with >= 40 kg to < 50 kg body weight, Group B with >= 20 kg to < 30 kg body weight, Group B with >= 30 kg to < 40 kg body weight, Group B with >= 40 kg to < 50 kg body weight, Participants with >= 50 kg body weight |
| RitonavirRitonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks. | Drug | Group A with >= 20 kg to < 30 kg body weight, Group A with >= 30 kg to < 40 kg body weight, Group A with >= 40 kg to < 50 kg body weight, Group B with >= 20 kg to < 30 kg body weight, Group B with >= 30 kg to < 40 kg body weight, Group B with >= 40 kg to < 50 kg body weight, Participants with >= 50 kg body weight |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 1
Time frame: Week 2
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Predose Plasma Concentration (C0) - Part 1
Time frame: Week 2
The C0 is the predose plasma concentration.
Maximum Observed Plasma Concentration (Cmax) - Part 1
Time frame: Week 2
The Cmax is the maximum observed plasma concentration.
Recommended Dose of TMC114 per Body Weight
Time frame: Week 2
The recommended dose of TMC114 will be determined in participants with a body weight: greater than and equal to 20 Kilogram (kg) to less than 30 kg; greater than and equal to 30 kg to less than 40 kg; and greater than 40 kg.
Change From Baseline in Plasma Viral Load at Week 2 - Part 1
Time frame: Baseline and Week 2
Plasma viral load levels will be determined using Roche amplicor human immunodeficiency virus (HIV)-1 monitor test (Version 1.5).
Change From Baseline in Plasma Viral Load at Week 24- Part 2
Time frame: Baseline and Week 24
Plasma viral load levels will be determined using Roche amplicor HIV-1 monitor test (Version 1.5).
Number of Participants With Adverse Events
Time frame: Week 2
Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
Number of Participants With Adverse Events
Time frame: Week 24
Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
6 secondary outcomes
Change From Baseline in Plasma Viral Load at Week 48 - Part 2
Time frame: Baseline and Week 48
Change from Baseline in Cluster of Differentiation 4 (CD4+) cell count - Part 2
Time frame: Baseline and Week 48
Number of Participants With Resistance - Part 2
Time frame: Week 48
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 2
Time frame: Week 48
Predose Plasma Concentration (C0) - Part 2
Time frame: Week 48
Oral Clearance (CL/F) - Part 2
Time frame: Week 48
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 8 Jul 2013.
- Results publication: PubMed 19724191Blanche S, Bologna R, Cahn P, Rugina S, Flynn P, Fortuny C, Vis P, Sekar V, van Baelen B, Dierynck I, Spinosa-Guzman S. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009 Sep 24;23(15):2005-13. doi: 10.1097/QAD.0b013e328330abaa.
- A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and AdolescentsLink 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.
Tibotec Pharmaceuticals Limited, Ireland Clinical Trial study director
Tibotec Pharmaceuticals, Ireland
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC114 and Ritonavir in people with HIV-1 and HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 22 sites in 8 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 5 inclusion and 5 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Brazil, South Africa, Canada, Romania and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 1 (time frame: Week 2). The study lists 8 primary outcomes in all. 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 NCT00355524, 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 8 Jul 2013.