HIV InfectionsPhase 1/2NCT00016718
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
A Phase 1/2 study testing Didanosine (ddI), Efavirenz (EFV) and Emtricitabine (FTC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in 2 countries.
Trial summary
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). Read more about this study
- Who is it for?
- Ages 90 days to 21 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Didanosine (ddI), Efavirenz (EFV) and Emtricitabine (FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Aug 2001to Jan 2009
- Phase
- Phase 1/2
- 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 90 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected
- Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy
- Viral load of 5,000 copies/ml or more
- Any Center for Disease Control (CDC) classification and immune status
- Able to swallow study medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable forms of contraception
- female subjects of childbearing potential with a negative serum beta human chronic gonadotropin
Who cannot join
- Allergic to study medications or their formulations
- Kidney disease
- Positive for hepatitis B or C
- Acute opportunistic infection (OI) or bacterial infection requiring treatment at study entry
- Taking drugs to treat tuberculosis
- Taking anti-HIV drugs other than those included in this study
Show all 23Show fewer
- Hemoglobin >= grade 3 at screening
- Absolute Neutrophil counts >= grade 2 at screening
- Platelets >= Grade 2 at screening
- Bilirubin >= Grade 2 at screening
- SGOT (AST), SGPT(ALT) >= Grade 2 at screening
- Non-fasting triglycerides >= Grade 2 at screening. Confirmed by a 2nd determination >=100 mg/dl at fasting state
- Pancreatic amylase or total amylase+ lipase >= Grade 2 at screening
- Taking any investigational drugs
- Anti-cancer drugs within 1 year of study screening
- Serious medical event within 21 days of study screening
- Active or history of pancreatitis
- Require certain medications. Patients requiring short courses of steroids (less than 14 days) for asthma are not excluded.
- Active or history of significant peripheral neuropathy
- Difficulty with food or severe chronic diarrhea within 30 days before study entry
- Unable to eat at least 1 meal per day (or to feed at least 3 times per day, for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset
- Unable to swallow oral medications
- Pregnant or breastfeeding
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States16 sites
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 802181088
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, 021155724
Chicago Children's CRS
Chicago, Illinois, 606143394
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois
DUMC Ped. CRS
Durham, North Carolina, 277103499
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
St. Jude/UTHSC CRS
Memphis, Tennessee, 381052794
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
Nyu Ny Nichd Crs
New York, New York, 10016
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California
UCSF Pediatric AIDS CRS
San Francisco, California, 941430105
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 016550001
Puerto Rico2 sites
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 009365067
San Juan City Hosp. PR NICHD CRS
San Juan, 009367344
About this study
Official title: An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
Read the detailed description
Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults.
This Phase I/II open label study evaluated the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients. All study patients were either absolutely naive to antiretroviral therapy or had received less than or equal to 56 days perinatal prophylaxis or less than 7 days of cumulative antiretroviral therapy prior to study entry, and had a plasma screening plasma HIV-1 RNA levels >= 5000 copies/mL. This study was written to characterize the disposition of FTC, determine the PK data for ddI-EC QD, comparing the bio-availability of the enteric coated formulation with ddI pediatric powder for oral solution, and to provide insight into the age related pharmacokinetics differences observed in this and other studies.
HIV infected pediatric patients were stratified into three age Groups: Group 1: 90 days to <3 years of age; Group 2: 3 years to 12 years of age (inclusive); and Group 3: 13 to 21 years of age (inclusive). The initial study doses for the triple drug regimen was FTC, 6 mk/kg up to a maximum of 200 mg once daily, for EFV, the dose for age Group 1 was determined in PACTG 382 and dose adjusted for body size, and the doses for age Groups 2 and 3 were defined in the dosing table of the protocol of up to a maximum of 600 mg once daily as a capsule or 720 mg as an oral solution; for ddI, 240 mg/m2 up to a maximum of 400 mg once daily. Comparison of age groups was not required as per the protocol.
Patients were followed for a maximum of 192 weeks; all patients were to receive ddI, EFV, and FTC together once daily. Study visits occurred at study entry, Weeks 2,and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam occurred at all visits; urine collection occurred at selected visits. Intensive pharmacokinetic (PK) studies was done at Weeks 2 and 12 to determine if dose adjustments were required for any of the drugs. If virologic failure was determined, PK studies was repeated 4 weeks after adjustments in therapy. Parents or guardians were asked to complete treatment adherence questionnaires at some visits. Some patients were also asked to participate in an additional PK study after Week 16 or week 96.
- Conditions
- HIV Infections
- Being tested
- Didanosine (ddI), Efavirenz (EFV), Emtricitabine (FTC)
- Keywords
- Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, Deoxycytidine, Efavirenz, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didanosine (ddI)Drug
Also called Videx, Videx EC
Antiretroviral Didanosine (ddI) : 240 mg/m^2 up to a maximum of 400 mg once daily
Efavirenz (EFV)Drug
Also called Sustiva
Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution
Emtricitabine (FTC)Drug
Also called Emtriva
Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI) | Experimental | Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily Receives: Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC) |
| Age Group 2: 3 to 12 years of age (FTC, EFV, ddI) | Experimental | Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily Receives: Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC) |
| Age Group 2: 13 to 21 years of age (FTC, EFV, ddI) | Experimental | Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily Receives: Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.
Comparisons between age groups were not required as per protocol.
Measured: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3
Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.
Measured: At week 16
Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.
Measured: At week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startAug 2001
- Primary completionJan 2009
- Study completionJan 2009
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ross E. McKinney, Jr., MD, Study chair, Duke UniversityMobeen H. Rathore, MD, Study chair, Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016718
- Sponsor's protocol ID
- P1021
- Other IDs
- 10038, ACTG P1021, PACTG P1021, IMPAACT P1021
- Status last verified
- Sep 2017
- First submitted
- 31 May 2001
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. doi: 10.1097/00008480-200402000-00014.
PubMed 14758118Weinberg A, Dickover R, Britto P, Hu C, Patterson-Bartlett J, Kraimer J, Gutzman H, Shearer WT, Rathore M, McKinney R; PACTG 1021 team. Continuous improvement in the immune system of HIV-infected children on prolonged antiretroviral therapy. AIDS. 2008 Nov 12;22(17):2267-77. doi: 10.1097/QAD.0b013e3283189bb3.
PubMed 18981766
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00016718
- Acronym / sponsor ID
- P1021
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, Deoxycytidine, Efavirenz
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2001
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Posted 17 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
Detailed description
Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults.
This Phase I/II open label study evaluated the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients. All study patients were either absolutely naive to antiretroviral therapy or had received less than or equal to 56 days perinatal prophylaxis or less than 7 days of cumulative antiretroviral therapy prior to study entry, and had a plasma screening plasma HIV-1 RNA levels >= 5000 copies/mL. This study was written to characterize the disposition of FTC, determine the PK data for ddI-EC QD, comparing the bio-availability of the enteric coated formulation with ddI pediatric powder for oral solution, and to provide insight into the age related pharmacokinetics differences observed in this and other studies.
HIV infected pediatric patients were stratified into three age Groups: Group 1: 90 days to <3 years of age; Group 2: 3 years to 12 years of age (inclusive); and Group 3: 13 to 21 years of age (inclusive). The initial study doses for the triple drug regimen was FTC, 6 mk/kg up to a maximum of 200 mg once daily, for EFV, the dose for age Group 1 was determined in PACTG 382 and dose adjusted for body size, and the doses for age Groups 2 and 3 were defined in the dosing table of the protocol of up to a maximum of 600 mg once daily as a capsule or 720 mg as an oral solution; for ddI, 240 mg/m2 up to a maximum of 400 mg once daily. Comparison of age groups was not required as per the protocol.
Patients were followed for a maximum of 192 weeks; all patients were to receive ddI, EFV, and FTC together once daily. Study visits occurred at study entry, Weeks 2,and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam occurred at all visits; urine collection occurred at selected visits. Intensive pharmacokinetic (PK) studies was done at Weeks 2 and 12 to determine if dose adjustments were required for any of the drugs. If virologic failure was determined, PK studies was repeated 4 weeks after adjustments in therapy. Parents or guardians were asked to complete treatment adherence questionnaires at some visits. Some patients were also asked to participate in an additional PK study after Week 16 or week 96.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI) | Experimental | Drug: Didanosine (ddI), Drug: Efavirenz (EFV), Drug: Emtricitabine (FTC)Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily |
| Age Group 2: 3 to 12 years of age (FTC, EFV, ddI) | Experimental | Drug: Didanosine (ddI), Drug: Efavirenz (EFV), Drug: Emtricitabine (FTC)Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily |
| Age Group 2: 13 to 21 years of age (FTC, EFV, ddI) | Experimental | Drug: Didanosine (ddI), Drug: Efavirenz (EFV), Drug: Emtricitabine (FTC)Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily |
Who may qualify
- Ages
- 90 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- HIV infected
- Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy
- Viral load of 5,000 copies/ml or more
- Any Center for Disease Control (CDC) classification and immune status
- Able to swallow study medications
Key exclusion criteria (23 listed)
- Allergic to study medications or their formulations
- Kidney disease
- Positive for hepatitis B or C
- Acute opportunistic infection (OI) or bacterial infection requiring treatment at study entry
- Taking drugs to treat tuberculosis
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 |
|---|---|---|
| Didanosine (ddI)Also: Videx, Videx ECAntiretroviral Didanosine (ddI) : 240 mg/m^2 up to a maximum of 400 mg once daily | Drug | Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI), Age Group 2: 13 to 21 years of age (FTC, EFV, ddI), Age Group 2: 3 to 12 years of age (FTC, EFV, ddI) |
| Efavirenz (EFV)Also: SustivaAntiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution | Drug | Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI), Age Group 2: 13 to 21 years of age (FTC, EFV, ddI), Age Group 2: 3 to 12 years of age (FTC, EFV, ddI) |
| Emtricitabine (FTC)Also: EmtrivaAntiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily | Drug | Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI), Age Group 2: 13 to 21 years of age (FTC, EFV, ddI), Age Group 2: 3 to 12 years of age (FTC, EFV, ddI) |
Primary outcome
Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
Time frame: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment. Comparisons between age groups were not required as per protocol.
Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
Time frame: At week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.
Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
Time frame: At week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14758118McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. doi: 10.1097/00008480-200402000-00014.
- Results publication: PubMed 18981766Weinberg A, Dickover R, Britto P, Hu C, Patterson-Bartlett J, Kraimer J, Gutzman H, Shearer WT, Rathore M, McKinney R; PACTG 1021 team. Continuous improvement in the immune system of HIV-infected children on prolonged antiretroviral therapy. AIDS. 2008 Nov 12;22(17):2267-77. doi: 10.1097/QAD.0b013e3283189bb3.
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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.
Ross E. McKinney, Jr., MD study chair
Duke University
Mobeen H. Rathore, MD study chair
Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Didanosine (ddI), Efavirenz (EFV) and Emtricitabine (FTC) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in 2 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 8 inclusion and 23 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 17 Oct 2017). 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?
Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment. (time frame: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3). The study lists 3 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 NCT00016718, 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 5 Nov 2021.