HIV InfectionsPhase 1NCT00076999
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
A Phase 1 study testing TPV oral solution and RTV oral solution in people with HIV Infections, run by Boehringer Ingelheim at 30 sites in 10 countries.
Trial summary
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- TPV oral solution and RTV oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 30 sitesin 10 countries
- Study dates
- Nov 2003to Jun 2010
- Phase
- Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females between 2 and 18 years of age.
- A confirmed diagnosis of HIV-1 infection as defined by two positive assays from two different samples taken at least two weeks apart. The two results may be any combination of the following:
- HIV ribonucleic acid (RNA) detected by reverse transcriptase (RT)-polymerase chain reaction(PCR) or HIV proviral deoxyribonucleic acid (DNA) detected by PCR HIV culture p24 antigen detection Licensed HIV enzyme-linked immunosorbent assay (ELISA) with confirmatory Western blot
- Viral load > 1500 RNA copies/mL.
- Acceptable screening laboratory values indicative of adequate baseline organ function. Laboratory values are considered acceptable if severity is no higher than Grade 1 for all tests defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Pediatric Adverse Experiences (> 3 months of age) with the following exceptions:
- Grade 2 gamma-glutamyl transferase Grade 2 cholesterol Grade 2 triglycerides
Show all 9Show fewer
- Signed informed consent prior to study participation from the patient or a legal guardian.
- Active assent must be given by the patient if the child and/or adolescent is capable of understanding the provided study information (this applies to children with the intellectual age of 7 years or greater)
- In the opinion of the investigator, an ability to take medications and comply with the requirements of the protocol.
Who cannot join
- Female patients of childbearing potential who:
- have a positive serum pregnancy test at screening are breast feeding are planning on becoming pregnant are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam)
- Active hepatitis B or C disease defined as hepatitis B surface antigen (HBsAg) positivity or hepatitis C (HCV) antibody or RNA positivity with aspartate aminotransferase(AST)/ alanine aminotransferase(ALT) > Grade 2.
- Life expectancy < 12 months.
- Patients who are unwilling to abstain from ingesting contraindicated medications and substances which may significantly affect plasma levels of the study medications, notably:
- Grapefruit juice or Seville oranges Herbal preparations containing St. John's Wort or milk thistle Garlic supplements
Show all 12Show fewer
- Active substance abuse.
- Use of investigational medications or vaccines within 28 days before study entry or during the trial. Some expanded access antiretroviral medications may be acceptable, but must be approved by sponsor.
- Requirement for any therapy for malignancy or immunomodulatory drug (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2) within 28 days of study entry. Replacement intravenous gamma globulin treatment is acceptable.
- Any active opportunistic infection within 28 days before study entry or other clinically significant findings that may compromise the outcome of the study.
- Patients with malabsorption, severe chronic diarrhea or vomiting (more than two episodes of moderate or severe intensity, not attributed to medication therapy and lasting more than four days) within 28 days of the study.
- Evidence or symptoms of encephalopathy or developmental delay that would reduce compliance.
Trial locations and contacts
30 sites in 10 countries.
30 sites in 10 countries
United States9 sites
1182.14.00004 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1182.14.00002 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
1182.14.00010 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
1182.14.00003 Boehringer Ingelheim Investigational Site
Houston, Texas
1182.14.00001 Boehringer Ingelheim Investigational Site
Los Angeles, California
1182.14.00006 Boehringer Ingelheim Investigational Site
Los Angeles, California
1182.14.00007 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1182.14.00008 Boehringer Ingelheim Investigational Site
North Worcester, Massachusetts
1182.14.00009 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
France6 sites
1182.14.33004 Boehringer Ingelheim Investigational Site
Lyon
1182.14.33005 Boehringer Ingelheim Investigational Site
Nantes
1182.14.33001 Boehringer Ingelheim Investigational Site
Paris
1182.14.33002 Boehringer Ingelheim Investigational Site
Paris
1182.14.33003 Boehringer Ingelheim Investigational Site
Paris
1182.14.33006 Boehringer Ingelheim Investigational Site
Paris
Germany3 sites
1182.14.49002 Boehringer Ingelheim Investigational Site
Berlin
1182.14.49001 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1182.14.49004 Boehringer Ingelheim Investigational Site
München
Canada2 sites
1182.14.11001 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.14.11002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
Italy2 sites
1182.14.39001 Boehringer Ingelheim Investigational Site
Padova
1182.14.39003 Boehringer Ingelheim Investigational Site
Roma
Mexico2 sites
1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)
México, D.F.
1182.14.52002
México, D.F.
Spain2 sites
1182.14.34002 Boehringer Ingelheim Investigational Site
Barcelona
1182.14.34001 Boehringer Ingelheim Investigational Site
Madrid
Puerto Rico1 site
1182.14.00005 Boehringer Ingelheim Investigational Site
San Juan
About this study
Official title: Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
- Conditions
- HIV Infections
- Being tested
- TPV oral solution, RTV oral solution
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV oral solutionDrug
Tipranavir oral solution
TPV oral solutionDrug
Tipranavir oral solution
RTV oral solutionDrug
Ritonavir oral solution
RTV oral solutionDrug
Ritonavir oral solution
| Study group | Role | What they receive |
|---|---|---|
| TPV/r 290/115 mg/m^2 | Experimental | TPV and RTV oral solution low dose Receives: Drug: TPV oral solution; Drug: RTV oral solution |
| TPV/r 375/150 mg/m^2 | Experimental | TPV and RTV oral solution high dose Receives: Drug: TPV oral solution; Drug: RTV oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Measured: up to 288 weeks
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Measured: up to 288 weeks
Secondary outcomes (25)
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Measured: baseline, week 24
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Measured: baseline, week 48
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Measured: baseline, week 100
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Measured: baseline, week 24
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Measured: baseline, week 48
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Measured: baseline, week 100
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Measured: baseline, week 24
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Measured: baseline, week 48
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Measured: baseline, week 100
Baseline Median Viral Load log10 Copies/mL
Measured: baseline
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Measured: baseline, week 24
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Measured: baseline, week 48
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Measured: baseline, week 100
Baseline Median CD4+ Cell Count (Cells/mm3)
Measured: baseline
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Measured: baseline, week 24
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Measured: baseline, week 48
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Measured: baseline, week 100
Median Baseline CD4 Percent
Percentage of lymphocytes that are CD4 cells
Measured: baseline
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Measured: baseline, week 24
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Measured: baseline, week 48
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
Percentage of lymphocytes that are CD4 cells
Measured: baseline, week 100
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Measured: week 8
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Measured: week 16
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Measured: week 24
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
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 posted10 Feb 2004 (estimated)
- Study startNov 2003
- Primary completionJun 2010
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076999
- Sponsor's protocol ID
- 1182.14
- Status last verified
- Apr 2014
- First submitted
- 9 Feb 2004
- Last updated
- 12 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.
PubMed 23995585Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.
PubMed 18753862
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
- ClinicalTrials.gov ID
- NCT00076999
- Acronym / sponsor ID
- 1182.14
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jun 2010 (actual)
- First posted
- 10 Feb 2004 (estimated)
- Results
- Posted 25 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPV/r 290/115 mg/m^2 | Experimental | Drug: TPV oral solution, Drug: RTV oral solutionTPV and RTV oral solution low dose |
| TPV/r 375/150 mg/m^2 | Experimental | Drug: TPV oral solution, Drug: RTV oral solutionTPV and RTV oral solution high dose |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Males and females between 2 and 18 years of age.
- A confirmed diagnosis of HIV-1 infection as defined by two positive assays from two different samples taken at least two weeks apart. The two results may be any combination of the following:
- HIV ribonucleic acid (RNA) detected by reverse transcriptase (RT)-polymerase chain reaction(PCR) or HIV proviral deoxyribonucleic acid (DNA) detected by PCR HIV culture p24 antigen detection Licensed HIV enzyme-linked immunosorbent assay (ELISA) with confirmatory Western blot
- Viral load > 1500 RNA copies/mL.
- Acceptable screening laboratory values indicative of adequate baseline organ function. Laboratory values are considered acceptable if severity is no higher than Grade 1 for all tests defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Pediatric Adverse Experiences (> 3 months of age) with the following exceptions:
Key exclusion criteria (12 listed)
- Female patients of childbearing potential who:
- have a positive serum pregnancy test at screening are breast feeding are planning on becoming pregnant are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam)
- Active hepatitis B or C disease defined as hepatitis B surface antigen (HBsAg) positivity or hepatitis C (HCV) antibody or RNA positivity with aspartate aminotransferase(AST)/ alanine aminotransferase(ALT) > Grade 2.
- Life expectancy < 12 months.
- Patients who are unwilling to abstain from ingesting contraindicated medications and substances which may significantly affect plasma levels of the study medications, notably:
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 |
|---|---|---|
| TPV oral solutionTipranavir oral solution | Drug | TPV/r 290/115 mg/m^2 |
| TPV oral solutionTipranavir oral solution | Drug | TPV/r 375/150 mg/m^2 |
| RTV oral solutionRitonavir oral solution | Drug | TPV/r 290/115 mg/m^2 |
| RTV oral solutionRitonavir oral solution | Drug | TPV/r 375/150 mg/m^2 |
Primary outcome
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Time frame: up to 288 weeks
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Time frame: up to 288 weeks
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
25 secondary outcomes
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Time frame: baseline, week 24
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Time frame: baseline, week 48
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Time frame: baseline, week 100
Baseline Median Viral Load log10 Copies/mL
Time frame: baseline
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
Time frame: baseline, week 24
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
Time frame: baseline, week 48
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
Time frame: baseline, week 100
Baseline Median CD4+ Cell Count (Cells/mm3)
Time frame: baseline
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
Time frame: baseline, week 24
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
Time frame: baseline, week 48
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
Time frame: baseline, week 100
Median Baseline CD4 Percent
Time frame: baseline
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
Time frame: baseline, week 24
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
Time frame: baseline, week 48
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
Time frame: baseline, week 100
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Time frame: week 8
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Time frame: week 16
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Time frame: week 24
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Time frame: week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23995585Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.
- Derived from this study: PubMed 18753862Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.
- Related InfoLink 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
30 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPV oral solution and RTV oral solution in people with HIV Infections, run by Boehringer Ingelheim at 30 sites in 10 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 9 inclusion and 12 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, France, Germany, Brazil, Canada and 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 25 Jul 2011). 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 Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation (time frame: up to 288 weeks). The study lists 2 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 NCT00076999, which also lists 2 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 12 May 2014.