HIV InfectionsNCT00428116
Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya
A study testing HAART in people with HIV Infections, run by University of Washington.
Trial summary
Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART) initiation is started in infants younger than 12 months. Read more about this study
- Who is it for?
- Ages Up to 54 months
- Conditions the study is for
- HIV Infections
- What is being tested?
- HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Dec 2014
- Phase
- Interventional
- 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 Up to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants newly initiating HAART
- Less than 13 months of age
- HIV-1 DNA detection with confirmation (positive on two HIV-1 DNA filter paper tests)
- Caregiver of infant plans to reside in Nairobi for at least 3 years (reported by caregiver)
- Caregiver is able to provide sufficient location information
- Infants already receiving HAART
Show all 15Show fewer
- Initiated HAART at <13 months of age
- Records confirming HIV positive status
- Documentation of CD4% and weight prior to HAART initiation
- Must be on 1st line drug regimen
- Eligibility for randomization:
- Completed 24 months of treatment with HAART
- Normalized growth: weight for height z-score (WHZ) > -0.5; Child's weight must be above the 5th weight-for-age percentile and the weight curve must not be flat or falling (i.e. cross 2 major percentile lines or more over the past 3 months)
- CD4% > 25
- Children who recently initiated or who require anti-tuberculosis treatment at the time of randomization will be ineligible for randomization.
Who cannot join
None listed.
About this study
Official title: Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya (0-4.5 Month Randomized Controlled Trial)
Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART) initiation is started in infants younger than 12 months. A problem with this approach is that it obligates infants to life-long therapy, which may be associated with cumulative drug toxicity, poor adherence, and treatment failure. Early HAART for prevention of mortality during the first 2 years of life has potential to salvage immune function and alter viral set-point, allowing withdrawal of therapy, perhaps for several years, until subsequent CD4% decline requires it. This untested approach is attractive because it combines the survival benefits of early pediatric HAART therapy with the benefits of antiretroviral deferral.
One hundred and fifty infants who initiated HAART at <13 months of age will be treated with HAART regimen for 24 months after which those who have immune reconstitution and adequate growth (~100) will be randomized to continued versus deferred therapy. Clinical outcomes, growth, and toxicity will be compared in these children to determine if interruption is a safe and beneficial strategy. Follow-up in this studies will be closely monitored by an external Data Safety and Monitoring Board (DSMB).
Read the detailed description
Hypothesis: Deferring antiretroviral therapy in infants who have immune reconstitution and adequate growth following early therapy of primary infection (initiated HAART during primary infection at less than 13 months of age) will not compromise clinical status or growth and may spare antiretroviral toxicity.
Specific Aim/Primary Objective: To compare growth and morbidity in infants (who initiated HAART during primary infection at less than or equal to 13 months of age with subsequently normalized CD4% and growth following 24 months of HAART) randomized to deferred versus continuous therapy and followed for an additional 18 months.
Secondary Aim/Secondary Objective: To determine predictors of non-progression of HIV among the infants, including: age, adherence, HIV-1 specific immune responses, baseline HIV-1 RNA, CD4 percent and immune activation.
Design: Randomized clinical trial involving HIV-1 treatment of infants (<13 months old) for 24 months, followed by randomization and 18 months follow-up of children randomized to continued versus deferred treatment. This trial is unblinded.
Population: HIV-1 infected infants (<13 months) newly initiating HAART and HIV-1 infected infants already receiving HAART who initiated HAART at age <13 months will be enrolled. After 24 months of treatment follow-up, children with CD4% > 25% and normalized growth will be retained in the study and randomized.
Sample size: 150 infants will be enrolled of which 100 are expected to be eligible for randomization (50 in each arm).
Treatment: All infants will be treated with HAART according to WHO and Kenyan national guidelines. The specific regimens that will be used as a part of this study are:
First line regimen
- AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)
- d4T/3TC/NVP (stavudine/lamivudine/nevirapine)
- AZT/3TC/ABC (zidovudine/lamivudine/abacavir)
- d4T/3TC/ABC (stavudine/lamivudine/abacavir)
- ABC/3TC/NVP (abacavir/lamivudine/nevirapine)
Second line regimen - ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir (Kaletra))
For infants with prior exposure to nevirapine as part of PMTCT:
First line regimen
- AZT/3TC/LPV/r (zidovudine/lamivudine/lopinavir-ritonavir (kaletra))
- Conditions
- HIV Infections
- Being tested
- HAART
- Keywords
- HIV-1, Pediatric, HAART, 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.
HAARTDrug
Combination first line antiretrovirals as previously described.
| Study group | Role | What they receive |
|---|---|---|
| Interrupted HAART | No intervention | After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months. |
| Continued HAART | Active comparator | After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months. Receives: Drug: HAART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth at 18 Months Post-randomization
Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.
Measured: 18 months of post-randomization follow-up
Secondary outcomes (1)
Morbidity
severe adverse events including death, pneumonia, diarrhea, and other adverse events
Measured: 18 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2013
- Study completionDec 2014
Why it stopped: DSMB recommended termination because TI was safe but not durable.
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 (10)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 University of WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Nairobi, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Grace John-Stewart, University of Washington
- Investigators
- Dalton Wamalwa, MMed, MPH, Principal investigator, Department of Paediatrics and Child Health, Kenyatta National Hospital, University of NairobiGrace C John-Stewart, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428116
- Sponsor's protocol ID
- STUDY00001675
- Other IDs
- R01HD023412
- Status last verified
- Jun 2018
- First submitted
- 22 Jan 2007
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wamalwa D, Benki-Nugent S, Langat A, Tapia K, Ngugi E, Moraa H, Maleche-Obimbo E, Otieno V, Inwani I, Richardson BA, Chohan B, Overbaugh J, John-Stewart GC. Treatment interruption after 2-year antiretroviral treatment initiated during acute/early HIV in infancy. AIDS. 2016 Sep 24;30(15):2303-13. doi: 10.1097/QAD.0000000000001158.
PubMed 27177316Njuguna IN, Wagner AD, Cranmer LM, Otieno VO, Onyango JA, Chebet DJ, Okinyi HM, Benki-Nugent S, Maleche-Obimbo E, Slyker JA, John-Stewart GC, Wamalwa DC. Hospitalized Children Reveal Health Systems Gaps in the Mother-Child HIV Care Cascade in Kenya. AIDS Patient Care STDS. 2016 Mar;30(3):119-24. doi: 10.1089/apc.2015.0239.
PubMed 27308805Sridharan G, Wamalwa D, John-Stewart G, Tapia K, Langat A, Moraa Okinyi H, Adhiambo J, Chebet D, Maleche-Obimbo E, Karr CJ, Benki-Nugent S. High Viremia and Wasting Before Antiretroviral Therapy Are Associated With Pneumonia in Early-Treated HIV-Infected Kenyan Infants. J Pediatric Infect Dis Soc. 2017 Sep 1;6(3):245-252. doi: 10.1093/jpids/piw038.
PubMed 27481854Asbjornsdottir KH, Hughes JP, Wamalwa D, Langat A, Slyker JA, Okinyi HM, Overbaugh J, Benki-Nugent S, Tapia K, Maleche-Obimbo E, Rowhani-Rahbar A, John-Stewart G. Differences in virologic and immunologic response to antiretroviral therapy among HIV-1-infected infants and children. AIDS. 2016 Nov 28;30(18):2835-2843. doi: 10.1097/QAD.0000000000001244.
PubMed 27603293Wagner A, Slyker J, Langat A, Inwani I, Adhiambo J, Benki-Nugent S, Tapia K, Njuguna I, Wamalwa D, John-Stewart G. High mortality in HIV-infected children diagnosed in hospital underscores need for faster diagnostic turnaround time in prevention of mother-to-child transmission of HIV (PMTCT) programs. BMC Pediatr. 2015 Feb 15;15:10. doi: 10.1186/s12887-015-0325-8.
PubMed 25886564Benki-Nugent S, Eshelman C, Wamalwa D, Langat A, Tapia K, Okinyi HM, John-Stewart G. Correlates of age at attainment of developmental milestones in HIV-infected infants receiving early antiretroviral therapy. Pediatr Infect Dis J. 2015 Jan;34(1):55-61. doi: 10.1097/INF.0000000000000526.
PubMed 25144793Slyker JA, Casper C, Tapia K, Richardson B, Bunts L, Huang ML, Wamalwa D, Benki-Nugent S, John-Stewart G. Accelerated suppression of primary Epstein-Barr virus infection in HIV-infected infants initiating lopinavir/ritonavir-based versus nevirapine-based combination antiretroviral therapy. Clin Infect Dis. 2014 May;58(9):1333-7. doi: 10.1093/cid/ciu088. Epub 2014 Feb 18.
PubMed 24550373Langat A, Benki-Nugent S, Wamalwa D, Tapia K, Ngugi E, Diener L, Richardson BA, Melvin A, John-Stewart GC. Lipid changes in Kenyan HIV-1-infected infants initiating highly active antiretroviral therapy by 1 year of age. Pediatr Infect Dis J. 2013 Jul;32(7):e298-304. doi: 10.1097/INF.0b013e31828afb2a.
PubMed 23385950Benki-Nugent SF, Martopullo I, Laboso T, Tamasha N, Wamalwa DC, Tapia K, Langat A, Maleche-Obimbo E, Marra CM, Bangirana P, Boivin MJ, John-Stewart GC. High Plasma Soluble CD163 During Infancy Is a Marker for Neurocognitive Outcomes in Early-Treated HIV-Infected Children. J Acquir Immune Defic Syndr. 2019 May 1;81(1):102-109. doi: 10.1097/QAI.0000000000001979.
PubMed 30768490Benki-Nugent S, Wamalwa D, Langat A, Tapia K, Adhiambo J, Chebet D, Okinyi HM, John-Stewart G. Comparison of developmental milestone attainment in early treated HIV-infected infants versus HIV-unexposed infants: a prospective cohort study. BMC Pediatr. 2017 Jan 17;17(1):24. doi: 10.1186/s12887-017-0776-1.
PubMed 28095807
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya (0-4.5 Month Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT00428116
- Acronym / sponsor ID
- STUDY00001675
- Conditions
- HIV Infections
- Keywords
- HIV-1, Pediatric, HAART, Treatment Naive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommended termination because TI was safe but not durable.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Nairobi, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 20 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART) initiation is started in infants younger than 12 months. A problem with this approach is that it obligates infants to life-long therapy, which may be associated with cumulative drug toxicity, poor adherence, and treatment failure. Early HAART for prevention of mortality during the first 2 years of life has potential to salvage immune function and alter viral set-point, allowing withdrawal of therapy, perhaps for several years, until subsequent CD4% decline requires it. This untested approach is attractive because it combines the survival benefits of early pediatric HAART therapy with the benefits of antiretroviral deferral.
One hundred and fifty infants who initiated HAART at <13 months of age will be treated with HAART regimen for 24 months after which those who have immune reconstitution and adequate growth (~100) will be randomized to continued versus deferred therapy. Clinical outcomes, growth, and toxicity will be compared in these children to determine if interruption is a safe and beneficial strategy. Follow-up in this studies will be closely monitored by an external Data Safety and Monitoring Board (DSMB).
Detailed description
Hypothesis: Deferring antiretroviral therapy in infants who have immune reconstitution and adequate growth following early therapy of primary infection (initiated HAART during primary infection at less than 13 months of age) will not compromise clinical status or growth and may spare antiretroviral toxicity.
Specific Aim/Primary Objective: To compare growth and morbidity in infants (who initiated HAART during primary infection at less than or equal to 13 months of age with subsequently normalized CD4% and growth following 24 months of HAART) randomized to deferred versus continuous therapy and followed for an additional 18 months.
Secondary Aim/Secondary Objective: To determine predictors of non-progression of HIV among the infants, including: age, adherence, HIV-1 specific immune responses, baseline HIV-1 RNA, CD4 percent and immune activation.
Design: Randomized clinical trial involving HIV-1 treatment of infants (<13 months old) for 24 months, followed by randomization and 18 months follow-up of children randomized to continued versus deferred treatment. This trial is unblinded.
Population: HIV-1 infected infants (<13 months) newly initiating HAART and HIV-1 infected infants already receiving HAART who initiated HAART at age <13 months will be enrolled. After 24 months of treatment follow-up, children with CD4% > 25% and normalized growth will be retained in the study and randomized.
Sample size: 150 infants will be enrolled of which 100 are expected to be eligible for randomization (50 in each arm).
Treatment: All infants will be treated with HAART according to WHO and Kenyan national guidelines. The specific regimens that will be used as a part of this study are:
First line regimen
- AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)
- d4T/3TC/NVP (stavudine/lamivudine/nevirapine)
- AZT/3TC/ABC (zidovudine/lamivudine/abacavir)
- d4T/3TC/ABC (stavudine/lamivudine/abacavir)
- ABC/3TC/NVP (abacavir/lamivudine/nevirapine)
Second line regimen - ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir (Kaletra))
For infants with prior exposure to nevirapine as part of PMTCT:
First line regimen
- AZT/3TC/LPV/r (zidovudine/lamivudine/lopinavir-ritonavir (kaletra))
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted HAART | No intervention | –After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months. |
| Continued HAART | Active comparator | Drug: HAARTAfter 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months. |
Who may qualify
- Ages
- Up to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Infants newly initiating HAART
- Less than 13 months of age
- HIV-1 DNA detection with confirmation (positive on two HIV-1 DNA filter paper tests)
- Caregiver of infant plans to reside in Nairobi for at least 3 years (reported by caregiver)
- Caregiver is able to provide sufficient location information
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HAARTCombination first line antiretrovirals as previously described. | Drug | Continued HAART |
Primary outcome
Growth at 18 Months Post-randomization
Time frame: 18 months of post-randomization follow-up
Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.
1 secondary outcome
Morbidity
Time frame: 18 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27177316Wamalwa D, Benki-Nugent S, Langat A, Tapia K, Ngugi E, Moraa H, Maleche-Obimbo E, Otieno V, Inwani I, Richardson BA, Chohan B, Overbaugh J, John-Stewart GC. Treatment interruption after 2-year antiretroviral treatment initiated during acute/early HIV in infancy. AIDS. 2016 Sep 24;30(15):2303-13. doi: 10.1097/QAD.0000000000001158.
- Results publication: PubMed 27308805Njuguna IN, Wagner AD, Cranmer LM, Otieno VO, Onyango JA, Chebet DJ, Okinyi HM, Benki-Nugent S, Maleche-Obimbo E, Slyker JA, John-Stewart GC, Wamalwa DC. Hospitalized Children Reveal Health Systems Gaps in the Mother-Child HIV Care Cascade in Kenya. AIDS Patient Care STDS. 2016 Mar;30(3):119-24. doi: 10.1089/apc.2015.0239.
- Results publication: PubMed 27481854Sridharan G, Wamalwa D, John-Stewart G, Tapia K, Langat A, Moraa Okinyi H, Adhiambo J, Chebet D, Maleche-Obimbo E, Karr CJ, Benki-Nugent S. High Viremia and Wasting Before Antiretroviral Therapy Are Associated With Pneumonia in Early-Treated HIV-Infected Kenyan Infants. J Pediatric Infect Dis Soc. 2017 Sep 1;6(3):245-252. doi: 10.1093/jpids/piw038.
- Results publication: PubMed 27603293Asbjornsdottir KH, Hughes JP, Wamalwa D, Langat A, Slyker JA, Okinyi HM, Overbaugh J, Benki-Nugent S, Tapia K, Maleche-Obimbo E, Rowhani-Rahbar A, John-Stewart G. Differences in virologic and immunologic response to antiretroviral therapy among HIV-1-infected infants and children. AIDS. 2016 Nov 28;30(18):2835-2843. doi: 10.1097/QAD.0000000000001244.
- Results publication: PubMed 25886564Wagner A, Slyker J, Langat A, Inwani I, Adhiambo J, Benki-Nugent S, Tapia K, Njuguna I, Wamalwa D, John-Stewart G. High mortality in HIV-infected children diagnosed in hospital underscores need for faster diagnostic turnaround time in prevention of mother-to-child transmission of HIV (PMTCT) programs. BMC Pediatr. 2015 Feb 15;15:10. doi: 10.1186/s12887-015-0325-8.
- Results publication: PubMed 25144793Benki-Nugent S, Eshelman C, Wamalwa D, Langat A, Tapia K, Okinyi HM, John-Stewart G. Correlates of age at attainment of developmental milestones in HIV-infected infants receiving early antiretroviral therapy. Pediatr Infect Dis J. 2015 Jan;34(1):55-61. doi: 10.1097/INF.0000000000000526.
- Results publication: PubMed 24550373Slyker JA, Casper C, Tapia K, Richardson B, Bunts L, Huang ML, Wamalwa D, Benki-Nugent S, John-Stewart G. Accelerated suppression of primary Epstein-Barr virus infection in HIV-infected infants initiating lopinavir/ritonavir-based versus nevirapine-based combination antiretroviral therapy. Clin Infect Dis. 2014 May;58(9):1333-7. doi: 10.1093/cid/ciu088. Epub 2014 Feb 18.
- Results publication: PubMed 23385950Langat A, Benki-Nugent S, Wamalwa D, Tapia K, Ngugi E, Diener L, Richardson BA, Melvin A, John-Stewart GC. Lipid changes in Kenyan HIV-1-infected infants initiating highly active antiretroviral therapy by 1 year of age. Pediatr Infect Dis J. 2013 Jul;32(7):e298-304. doi: 10.1097/INF.0b013e31828afb2a.
- Derived from this study: PubMed 30768490Benki-Nugent SF, Martopullo I, Laboso T, Tamasha N, Wamalwa DC, Tapia K, Langat A, Maleche-Obimbo E, Marra CM, Bangirana P, Boivin MJ, John-Stewart GC. High Plasma Soluble CD163 During Infancy Is a Marker for Neurocognitive Outcomes in Early-Treated HIV-Infected Children. J Acquir Immune Defic Syndr. 2019 May 1;81(1):102-109. doi: 10.1097/QAI.0000000000001979.
- Derived from this study: PubMed 28095807Benki-Nugent S, Wamalwa D, Langat A, Tapia K, Adhiambo J, Chebet D, Okinyi HM, John-Stewart G. Comparison of developmental milestone attainment in early treated HIV-infected infants versus HIV-unexposed infants: a prospective cohort study. BMC Pediatr. 2017 Jan 17;17(1):24. doi: 10.1186/s12887-017-0776-1.
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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.
Dalton Wamalwa, MMed, MPH principal investigator
Department of Paediatrics and Child Health, Kenyatta National Hospital, University of Nairobi
Grace C John-Stewart, MD, PhD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing HAART in people with HIV Infections, run by University of Washington.
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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2015). 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?
Growth at 18 Months Post-randomization (time frame: 18 months of post-randomization follow-up). 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 NCT00428116, which also lists 10 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 26 Jul 2018.