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NCT01418014 · ClinicalTrials.gov registry record
Adolescent Master Protocol
A clinical trial, sponsored by Harvard School of Public Health (HSPH).
- Completed
- Registry status
- 678
- Enrollment target
NCT01418014: Completed study, sponsored by Harvard School of Public Health (HSPH).
NCT01418014 is a clinical trial that has completed, run by Harvard School of Public Health (HSPH). The registered enrollment target is 678 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418014 has completed, sponsored by Harvard School of Public Health (HSPH).
- COMPLETED
- Registry status
- 678 participants
- Enrollment target
Study Summary
The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensuring that most previously infected American children have survived and are approaching adolescence. In addition, the number of HIV-infected adolescents worldwide is growing substantially in both resource-poor countries and in countries with increasing levels of health care. Therefore, there is a global cohort of children who have been living with HIV infection since birth who are aging into adolescence. Little is definitively known about the impact of HIV infection and its treatment on the maturation process in these children. AMP is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation, metabolic risk factors for cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment, language, hearing and behavioral function, and sexually transmitted infections (STI).
Primary Outcome
Assessed via measurement of height, weight, skinfold thickness, mid-upper arm and waist and hip circumference, nutrition and physical activity questionnaires ; subjects meeting growth trigger based on height measurements also have the following laboratory assessments: IGF-I, IGFBP-3, and GHBP. A growth hormone stimulation test may also be required at the recommendation of the endocrinologist.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 678 participants |
| Start Date | 2007-03 |
| Est. Completion | 2021-02 |
What the finished NCT01418014 record still lists
NCT01418014 is an observational study that tracks outcomes without assigning an intervention. The registered 678 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01418014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01418014 about?
NCT01418014 is a clinical study titled "Adolescent Master Protocol". The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensu...
What is the current status of trial NCT01418014?
This trial is currently completed. The enrollment target is 678 participants. The study started on 2007-03. Estimated completion is 2021-02.
Who is sponsoring clinical trial NCT01418014?
This trial is sponsored by Harvard School of Public Health (HSPH), which has 40 total clinical trials registered on ClinicalTrials.gov.
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