HIV-1NCT01771562
Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent
An observational study of HIV-1, run by ANRS, Emerging Infectious Diseases at 2 sites in Senegal.
Trial summary
The advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal HIV infection in Senegal. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- HIV-1
- How many people
- 330 participants
- Where
- 2 sitesSenegal
- Study dates
- Apr 2013to Apr 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: HIV-1 infected individuals age between 2 ans 16 years
Who may be able to join
- HIV-1 infection
- Age equal or above 2 years and bellow 16 years
- Follow-up in the participating site
- Informed consent signed by at least on of the parents or legal guardian who is aware of the child's HIV status
Who cannot join
- HIV-2 or HIV-1+2 infection
- children represented by a legal guardian who is not informed about the child's HIV status
- Unable to comply with study requirements or procedures according to the investigator's opinion
Trial locations and contacts
2 sites in 1 country.
Senegal2 sites
Hôpital d'enfant Albert Royer
Dakar
Hôpital Roi Baudoin
Guédiawaye
About this study
Official title: Assessment of Risk Factors of Nutritional and Metabolic Disorders in Children and Adolescent Receiving or Not Antiretroviral Treatment : Growing up With HIV in Senegal
The advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal HIV infection in Senegal. However, the transformation of HIV into a chronic disease needing lifelong antiretroviral treatment (ART) raises new challenges, among others related to a disturbance of glucose metabolism, lipid abnormalities, in addition to the potential effects on children's growth and puberty. Little is known on nutritional and metabolic changes in HIV-infected children on ART in Africa, while implementation of the latest WHO recommendations should eventually lead to an increase in the number of children on ART in this region. Moreover, bio-clinical evolution of untreated children is poorly documented in the African context. It therefore urgently needed to institute a cohort study to evaluate, in the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders and to characterize the risk factors of their occurrence in children and adolescents infected as they move through adolescent into adulthood.
- Conditions
- HIV-1
- Keywords
- HIV-1, Child, Adolescent, Growth, Lipodystrophy, ARV treatment, Senegal
- Medical subject headings
- Lipodystrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of delayed growth
Delayed growth is defined by height for age < -2 z-scores, wasting (%) by weight-for height < -2 z-scores and/or BMI-age < -2 z-scores
Measured: Baseline
Prevalence of delayed puberty
Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Measured: Baseline
Prevalence of lipodystrophy
Lipodystrophy (lipoatrophy, lipohypertrophy, combined forms) is defined by direct observation and by joint analysis of anthropometric measures associated with fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Measured: Baseline
Prevalence of blood lipids ans glucose abnormalities
Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Measured: Baseline
Incidence of delayed growth
Delayed growth is defined by height for age < -2 z-scores, wasting (%) by weight-for height < -2 z-scores and/or BMI-age < -2 z-scores
Measured: Annually for 3 years from the anniversary date of the study
Incidence of delayed puberty
Assessed by age of entry into puberty and the age of transition to a different Tanner stage
Measured: Annually for 3 years from the anniversary date of the study
Incidence of lipodystrophy
defined by direct observation and by joint analysis of anthropometric measures associated with changes in fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Measured: Annually for 3 years from the anniversary date of the study
Incidence of blood lipid and glucose abnormalities
Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Measured: Annually for 3 years from the anniversary date of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Philippe Msellati, MD, Principal investigator, IRD : French Research Institute for DevelopmentHaby Sy Signate, MD, Principal investigator, Hôpital d'Enfant Albert Royer, Dakar, SenegalNgagne Mbaye, MD, Principal investigator, Hôpital Roi Baudoin, Guédiawaye, Senegal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771562
- Sponsor's protocol ID
- ANRS 12279 MAGGSEN
- Status last verified
- May 2016
- First submitted
- 16 Jan 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cames C, Pascal L, Ba A, Mbodj H, Ouattara B, Diallo NF, Msellati P, Mbaye N, Sy Signate H, Blanche S, Diack A; MAGGSEN Cohort Study Group. Low prevalence of lipodystrophy in HIV-infected Senegalese children on long-term antiretroviral treatment: the ANRS 12279 MAGGSEN Pediatric Cohort Study. BMC Infect Dis. 2018 Aug 6;18(1):374. doi: 10.1186/s12879-018-3282-7.
PubMed 30081838Cames C, Varloteaux M, Have NN, Diom AB, Msellati P, Mbaye N, Mbodj H, Sy Signate H, Diack A; ANRS 12279 MAGGSEN Cohort Study Group. Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. Food Nutr Bull. 2017 Mar;38(1):27-36. doi: 10.1177/0379572116679053. Epub 2016 Nov 23.
PubMed 27881690
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Risk Factors of Nutritional and Metabolic Disorders in Children and Adolescent Receiving or Not Antiretroviral Treatment : Growing up With HIV in Senegal
- ClinicalTrials.gov ID
- NCT01771562
- Acronym / sponsor ID
- ANRS 12279 MAGGSEN
- Conditions
- HIV-1
- Keywords
- HIV-1, Child, Adolescent, Growth, Lipodystrophy, ARV treatment, Senegal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Jan 2013 (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 advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal HIV infection in Senegal. However, the transformation of HIV into a chronic disease needing lifelong antiretroviral treatment (ART) raises new challenges, among others related to a disturbance of glucose metabolism, lipid abnormalities, in addition to the potential effects on children's growth and puberty. Little is known on nutritional and metabolic changes in HIV-infected children on ART in Africa, while implementation of the latest WHO recommendations should eventually lead to an increase in the number of children on ART in this region. Moreover, bio-clinical evolution of untreated children is poorly documented in the African context. It therefore urgently needed to institute a cohort study to evaluate, in the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders and to characterize the risk factors of their occurrence in children and adolescents infected as they move through adolescent into adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV-1 infected individuals age between 2 ans 16 years
Key inclusion criteria (4 listed)
- HIV-1 infection
- Age equal or above 2 years and bellow 16 years
- Follow-up in the participating site
- Informed consent signed by at least on of the parents or legal guardian who is aware of the child's HIV status
Key exclusion criteria (3 listed)
- HIV-2 or HIV-1+2 infection
- children represented by a legal guardian who is not informed about the child's HIV status
- Unable to comply with study requirements or procedures according to the investigator's opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of delayed growth
Time frame: Baseline
Delayed growth is defined by height for age < -2 z-scores, wasting (%) by weight-for height < -2 z-scores and/or BMI-age < -2 z-scores
Prevalence of delayed puberty
Time frame: Baseline
Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Prevalence of lipodystrophy
Time frame: Baseline
Lipodystrophy (lipoatrophy, lipohypertrophy, combined forms) is defined by direct observation and by joint analysis of anthropometric measures associated with fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Prevalence of blood lipids ans glucose abnormalities
Time frame: Baseline
Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Incidence of delayed growth
Time frame: Annually for 3 years from the anniversary date of the study
Delayed growth is defined by height for age < -2 z-scores, wasting (%) by weight-for height < -2 z-scores and/or BMI-age < -2 z-scores
Incidence of delayed puberty
Time frame: Annually for 3 years from the anniversary date of the study
Assessed by age of entry into puberty and the age of transition to a different Tanner stage
Incidence of lipodystrophy
Time frame: Annually for 3 years from the anniversary date of the study
defined by direct observation and by joint analysis of anthropometric measures associated with changes in fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Incidence of blood lipid and glucose abnormalities
Time frame: Annually for 3 years from the anniversary date of the study
Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
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 20 May 2016.
- Derived from this study: PubMed 30081838Cames C, Pascal L, Ba A, Mbodj H, Ouattara B, Diallo NF, Msellati P, Mbaye N, Sy Signate H, Blanche S, Diack A; MAGGSEN Cohort Study Group. Low prevalence of lipodystrophy in HIV-infected Senegalese children on long-term antiretroviral treatment: the ANRS 12279 MAGGSEN Pediatric Cohort Study. BMC Infect Dis. 2018 Aug 6;18(1):374. doi: 10.1186/s12879-018-3282-7.
- Derived from this study: PubMed 27881690Cames C, Varloteaux M, Have NN, Diom AB, Msellati P, Mbaye N, Mbodj H, Sy Signate H, Diack A; ANRS 12279 MAGGSEN Cohort Study Group. Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. Food Nutr Bull. 2017 Mar;38(1):27-36. doi: 10.1177/0379572116679053. Epub 2016 Nov 23.
- Sponsor websiteLink 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.
Philippe Msellati, MD principal investigator
IRD : French Research Institute for Development
Haby Sy Signate, MD principal investigator
Hôpital d'Enfant Albert Royer, Dakar, Senegal
Ngagne Mbaye, MD principal investigator
Hôpital Roi Baudoin, Guédiawaye, Senegal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1, run by ANRS, Emerging Infectious Diseases at 2 sites in Senegal.
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 4 inclusion and 3 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Senegal. 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.
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?
Prevalence of delayed growth (time frame: Baseline). 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 NCT01771562, 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 20 May 2016.