HIV/AIDSAMPNCT01418014

Adolescent Master Protocol

An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 years and olderHealthy volunteers can take part
Conditions the study is for: HIV/AIDS
How many people: 678 participants
Where: 15 sitesin 2 countries
Study dates: Mar 2007to Feb 2021
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 7 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: HIV-infected and -uninfected children from 7 years of age (7th birthday) up to but not including the 16th birthday at the time of enrollment born to HIV-infected mothers. Participants will be children previously enrolled in any of the studies included on the list of approved studies for co-enrollment (see below) or has medical record documentation since birth of key medical data related to their HIV infection.

Who may be able to join

Perinatal HIV infection as documented in the medical record.
Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
Engaged in care and ART history is available.
Either: Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP as specified in the protocol. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols are listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history 2)Opportunistic Infection (OI) prophylaxis exposure history 3) Viral load and CD4 count history and 4) Major medical events history
Willingness to participate and provide parental/legal guardian permission with assent. Children who do not know their HIV infection status will not be excluded.
Exclusion criteria: HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record.

Show all 11Show fewer

HIV-Uninfected, HIV-Exposed Control Cohort
HIV-uninfected and born to an HIV-infected mother as documented in the medical record.
Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols will be listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history and 2) Major medical events history.
Willingness to participate and provide parental/legal guardian permission with assent.

Who cannot join

None listed.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

United States14 sites

University of Colorado Denver Health Sciences Center
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Children's Hospital Boston
Boston, Massachusetts, 02115
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Baylor College of Medicine
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33136
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Rutgers - New Jersey Medical School
Newark, New Jersey, 07101
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Bronx Lebanon Hospital Center
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461

Other trials in United States

Puerto Rico1 site

San Juan Research Hospital
San Juan, 00936

Other trials in Puerto Rico

About this study

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).

Read the detailed description

The primary objectives of AMP are:

To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social development, of pre-adolescents and adolescents with perinatal HIV infection as they move through adolescence into adulthood.
To identify infectious and non-infectious complications of HIV disease, including the toxicities of antiretroviral therapy (ART).
To investigate:

Cognitive and behavioral changes over time, including medication adherence, family and social function, and high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use;
Changes in language and hearing;
Changes in glucose metabolism, body composition, and bone mineralization;
Changes in lipid metabolism and other risk factors for cardiovascular disease;
Risk factors for secondary transmission of HIV; and
The occurrence and clinical course of cervical HPV infections among females.

The domain-specific aims of AMP are:

Growth and sexual maturation: To longitudinally track growth and sexual maturation and the factors that influence growth and maturation in HIV-infected children when compared to HIV-exposed but uninfected children.
Metabolic risk factors for cardiovascular disease: To characterize the emergence of abnormal glucose metabolism, lipid abnormalities, body composition and other risk factors for cardiovascular disease and identify the contributing influences in HIV-infected children when compared to HIV-exposed but uninfected children.
Cardiac function: To estimate the prevalence of cardiac structural and functional abnormalities in HIV-infected children and youth when compared to HIV-exposed but uninfected children.
Bone mineral density: To estimate the differences in bone mineral density of HIV-infected children when compared to HIV-exposed but uninfected children and to identify factors contributing to abnormal bone mineralization.
Neurologic, neurodevelopment, language, and behavioral function:

To examine cognitive and behavioral outcomes of HIV-infected children and adolescents, including high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use, neurodevelopmental impairment, school achievement and to compare them with an HIV-exposed but uninfected control cohort.
To examine non-adherence to antiretroviral therapy and predictors of non-adherence among HIV-infected children receiving ART.
To examine family and psychosocial factors associated with emotional and behavioral problems.

Adolescent gynecology and STI infection:

To evaluate the incidence of and risk factors for acquiring STIs/vaginal infections (C. trachomatis, N. gonorrhea, T. vaginalis, syphilis, genital warts, HPV, and HSV) for males and females, and in addition bacterial vaginosis for females.
To evaluate the incidence, predictors, and outcomes of pregnancy.

Conditions: HIV/AIDS
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01418014
Study group	Role	What they receive
Infected Cohort		Perinatally HIV-infected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment, engaged in care with ART treatment history available.
Uninfected Cohort		HIV-uninfected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment born to HIV-infected mothers.

What is being measured

The primary outcome is the main question the study is designed to answer.

Abnormal growth
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.
Measured: Annually for 10 years
Delayed sexual maturation
Assessed via tanner staging; subjects meeting the growth trigger based on the results of the tanner staging will also have the following laboratory assessments: morning LH, FSH, estradiol, and testosterone
Measured: Annually for 10 years except if subject reaches Tanner Stage 5
Abnormal bone mineral density
Assessed via DXA scan and x-ray for bone age; subjects meeting the BMD trigger based on the DXA also have the following laboratory assessments: TSH, calcium, 25-hydroxy-vitamin D, bone-specific alkaline, N-terminal telopeptide of type I collagen phosphatase, and PTH in real time and repository specimens for assay of pro-inflammatory cytokines (IL-1, IL-6, TNF-a)
Measured: Two DXAs, two years apart, per HIV-infected subject; one DXA per uninfected subject; X-ray at same time as DXA unless subject Tanner Stage 5
Dyslipidemia
Assessed via lipid testing; subjects meeting the metabolic trigger based on the results of the lipid tests also have the following measurements: endothelial dysfunction (I, E, P-selectins: V, I-CAM-1, endothelin-1, hs-CRP, homocysteine, apolipoprotein B, lipoprotein (a), and vWF antigen)
Measured: Annually for 10 years
Cardiac abnormalities
Assessed through the administration of echocardiograms and serum biomarkers (ProBNP)
Measured: Measured once per subject until study reached 400 echocardiograms
Hearing dysfunction
Assessed via audiologic evaluation conducted by an audiologist.
Measured: Once per subject.
Language dysfunction
Assessed using the Woodcock and CELF IV language tests
Measured: Annually for 10 years
Neurodevelopmental abnormalities
Assessed via the following neurodevelopmental tests: WISC IV, WAIS IV, BRIEF, Children's Color Trails Test, Trail Making Tests, WIAT-II screen, ABAS, Parent Child Relationship Inventory, BASC-2, Quality of Life Interview, Stressful Life Events Questionnaire, Monitoring the Future
Measured: Annually for 10 years
Substance Use
The assessment of sexual activity is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.
Measured: Annually starting at a minimum of 10 years of age for 10 years
Sexual Activity
The assessment of substance use is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.
Measured: Annually starting at a minimum of 10 years of age for 10 years
Pregnancy
Assessed via medical record review to record incidents of pregnancy
Measured: Annually for 10 years
Sexually Transmitted Infection
Assessed via medical record review to record results of clinically conducted STI and Pap testing and pelvic exams
Measured: Annually for 10 years
Mitochondrial dysfunction
Assessed via measurement of serum lactate levels, OXPHO immunoassays, mitochondrial specific oxidative stress, mtDNA copies/cell, mrRNA transcripts
Measured: Annually for 10 years
Lactic acidosis
Assessed through the measurement of blood lactate levels using a point-of-care lactate measuring device; a single venous lactate measurement will be conducted in cases where the POC lactate measure is elevated
Measured: Annually for 10 years
Renal abnormalities
Assessed through the following laboratory measurements: chemistry panel, urinalysis, protein/creatinine ratio, dip stick urine test
Measured: Annually for 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Feb 2021

First posted16 Aug 2011 (estimated)
Study startMar 2007
Primary completionFeb 2021
Study completionFeb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (112)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
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: 678 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01418014
Sponsor's protocol ID: HD052102 - PH200
Other IDs: PH200
Acronym: AMP
Status last verified: Jun 2025
First submitted: 22 Jul 2011
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: No

Publications

Kapetanovic S, Leister E, Nichols S, Miller T, Tassiopoulos K, Hazra R, Gelbard HA, Malee KM, Kammerer B, Mendez AJ, Williams PL; Pediatric HIV/AIDS Cohort Study Team. Relationships between markers of vascular dysfunction and neurodevelopmental outcomes in perinatally HIV-infected youth. AIDS. 2010 Jun 19;24(10):1481-91. doi: 10.1097/QAD.0b013e32833a241b.
PubMed 20539091
Van Dyke RB, Patel K, Siberry GK, Burchett SK, Spector SA, Chernoff MC, Read JS, Mofenson LM, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Antiretroviral treatment of US children with perinatally acquired HIV infection: temporal changes in therapy between 1991 and 2009 and predictors of immunologic and virologic outcomes. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):165-73. doi: 10.1097/QAI.0b013e318215c7b1.
PubMed 21407086
Siberry GK, Patel K, Van Dyke RB, Hazra R, Burchett SK, Spector SA, Paul ME, Read JS, Wiznia A, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study(PHACS). CD4+ lymphocyte-based immunologic outcomes of perinatally HIV-infected children during antiretroviral therapy interruption. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):223-9. doi: 10.1097/QAI.0b013e318218e068.
PubMed 21423022
Malee KM, Tassiopoulos K, Huo Y, Siberry G, Williams PL, Hazra R, Smith RA, Allison SM, Garvie PA, Kammerer B, Kapetanovic S, Nichols S, Van Dyke R, Seage GR 3rd, Mellins CA; Pediatric HIV/AIDS Cohort Study Team. Mental health functioning among children and adolescents with perinatal HIV infection and perinatal HIV exposure. AIDS Care. 2011 Dec;23(12):1533-44. doi: 10.1080/09540121.2011.575120.
PubMed 21702707
Mellins CA, Tassiopoulos K, Malee K, Moscicki AB, Patton D, Smith R, Usitalo A, Allison SM, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Behavioral health risks in perinatally HIV-exposed youth: co-occurrence of sexual and drug use behavior, mental health problems, and nonadherence to antiretroviral treatment. AIDS Patient Care STDS. 2011 Jul;25(7):413-22. doi: 10.1089/apc.2011.0025. Epub 2011 May 5.
PubMed 21992620
Geffner ME, Patel K, Miller TL, Hazra R, Silio M, Van Dyke RB, Borkowsky W, Worrell C, DiMeglio LA, Jacobson DL; Pediatric HIV/AIDS Cohort Study. Factors associated with insulin resistance among children and adolescents perinatally infected with HIV-1 in the pediatric HIV/AIDS cohort study. Horm Res Paediatr. 2011;76(6):386-91. doi: 10.1159/000332957. Epub 2011 Oct 26.
PubMed 22042056
Jacobson DL, Patel K, Siberry GK, Van Dyke RB, DiMeglio LA, Geffner ME, Chen JS, McFarland EJ, Borkowsky W, Silio M, Fielding RA, Siminski S, Miller TL; Pediatric HIV/AIDS Cohort Study. Body fat distribution in perinatally HIV-infected and HIV-exposed but uninfected children in the era of highly active antiretroviral therapy: outcomes from the Pediatric HIV/AIDS Cohort Study. Am J Clin Nutr. 2011 Dec;94(6):1485-95. doi: 10.3945/ajcn.111.020271. Epub 2011 Nov 2.
PubMed 22049166
Miller TI, Borkowsky W, DiMeglio LA, Dooley L, Geffner ME, Hazra R, McFarland EJ, Mendez AJ, Patel K, Siberry GK, Van Dyke RB, Worrell CJ, Jacobson DL; Pediatric HIV/AIDS Cohort Study (PHACS); Shearer W, Cooper N, Harris L, Purswani M, Baig M, Cintron A, Puga A, Navarro S, Patton D, Burchett S, Karthas N, Kammerer B, Yogev R, Malee K, Hunter S, Cagwin E, Wiznia A, Burey M, Nozyce M, Chen J, Gobs E, Grant M, Knapp K, Allison K, Garvie P, Acevedo-Flores M, Rios H, Olivera V, Silio M, Borne C, Sirois P, Spector S, Norris K, Nichols S, McFarland E, Barr E, Chambers C, Watson D, Messenger N, Belanger R, Dieudonne A, Bettica L, Adubato S, Scott G, Himic L, Willen E. Metabolic abnormalities and viral replication are associated with biomarkers of vascular dysfunction in HIV-infected children. HIV Med. 2012 May;13(5):264-75. doi: 10.1111/j.1468-1293.2011.00970.x. Epub 2011 Dec 4.
PubMed 22136114
Torre P 3rd, Zeldow B, Hoffman HJ, Buchanan A, Siberry GK, Rice M, Sirois PA, Williams PL; Pediatric HIVAIDS Cohort Study. Hearing loss in perinatally HIV-infected and HIV-exposed but uninfected children and adolescents. Pediatr Infect Dis J. 2012 Aug;31(8):835-41. doi: 10.1097/INF.0b013e31825b9524.
PubMed 22549437
Rice ML, Buchanan AL, Siberry GK, Malee KM, Zeldow B, Frederick T, Purswani MU, Hoffman HJ, Sirois PA, Smith R, Torre P 3rd, Allison SM, Williams PL. Language impairment in children perinatally infected with HIV compared to children who were HIV-exposed and uninfected. J Dev Behav Pediatr. 2012 Feb;33(2):112-23. doi: 10.1097/DBP.0b013e318241ed23.
PubMed 22179050
Siberry GK, Leister E, Jacobson DL, Foster SB, Seage GR 3rd, Lipshultz SE, Paul ME, Purswani M, Colin AA, Scott G, Shearer WT. Increased risk of asthma and atopic dermatitis in perinatally HIV-infected children and adolescents. Clin Immunol. 2012 Feb;142(2):201-8. doi: 10.1016/j.clim.2011.10.005. Epub 2011 Oct 30.
PubMed 22094294
Smith R, Chernoff M, Williams PL, Malee KM, Sirois PA, Kammerer B, Wilkins M, Nichols S, Mellins C, Usitalo A, Garvie P, Rutstein R; Pediatric HIV/AIDS Cohort Study (PHACS) Team. Impact of HIV severity on cognitive and adaptive functioning during childhood and adolescence. Pediatr Infect Dis J. 2012 Jun;31(6):592-8. doi: 10.1097/INF.0b013e318253844b.
PubMed 22592486
Tassiopoulos K, Moscicki AB, Mellins C, Kacanek D, Malee K, Allison S, Hazra R, Siberry GK, Smith R, Paul M, Van Dyke RB, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Sexual risk behavior among youth with perinatal HIV infection in the United States: predictors and implications for intervention development. Clin Infect Dis. 2013 Jan;56(2):283-90. doi: 10.1093/cid/cis816. Epub 2012 Nov 7.
PubMed 23139252
DiMeglio LA, Wang J, Siberry GK, Miller TL, Geffner ME, Hazra R, Borkowsky W, Chen JS, Dooley L, Patel K, van Dyke RB, Fielding RA, Gurmu Y, Jacobson DL; Pediatric HIVAIDS Cohort Study (PHACS). Bone mineral density in children and adolescents with perinatal HIV infection. AIDS. 2013 Jan 14;27(2):211-20. doi: 10.1097/QAD.0b013e32835a9b80.
PubMed 23032412
Purswani M, Patel K, Kopp JB, Seage GR 3rd, Chernoff MC, Hazra R, Siberry GK, Mofenson LM, Scott GB, Van Dyke RB; Pediatric HIVAIDS Cohort Study. Tenofovir treatment duration predicts proteinuria in a multiethnic United States Cohort of children and adolescents with perinatal HIV-1 infection. Pediatr Infect Dis J. 2013 May;32(5):495-500. doi: 10.1097/INF.0b013e31827f4eff.
PubMed 23249917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent Master Protocol
ClinicalTrials.gov ID: NCT01418014
Acronym / sponsor ID: AMP / HD052102 - PH200
Conditions: HIV/AIDS
Study type: Observational
Recruitment status: Completed
Enrolment: 678 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Neurological Disorders and Stroke (NINDS), Tulane University School of Medicine, National Institute of Dental and Craniofacial Research (NIDCR), NIH Office of AIDS Research (OAR)
Study start: Mar 2007 (actual)
Primary completion: Feb 2021 (actual)
Study completion: Feb 2021 (actual)
First posted: 16 Aug 2011 (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.

Detailed description

The primary objectives of AMP are:

To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social development, of pre-adolescents and adolescents with perinatal HIV infection as they move through adolescence into adulthood.
To identify infectious and non-infectious complications of HIV disease, including the toxicities of antiretroviral therapy (ART).
To investigate:

Cognitive and behavioral changes over time, including medication adherence, family and social function, and high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use;
Changes in language and hearing;
Changes in glucose metabolism, body composition, and bone mineralization;
Changes in lipid metabolism and other risk factors for cardiovascular disease;
Risk factors for secondary transmission of HIV; and
The occurrence and clinical course of cervical HPV infections among females.

The domain-specific aims of AMP are:

Growth and sexual maturation: To longitudinally track growth and sexual maturation and the factors that influence growth and maturation in HIV-infected children when compared to HIV-exposed but uninfected children.
Metabolic risk factors for cardiovascular disease: To characterize the emergence of abnormal glucose metabolism, lipid abnormalities, body composition and other risk factors for cardiovascular disease and identify the contributing influences in HIV-infected children when compared to HIV-exposed but uninfected children.
Cardiac function: To estimate the prevalence of cardiac structural and functional abnormalities in HIV-infected children and youth when compared to HIV-exposed but uninfected children.
Bone mineral density: To estimate the differences in bone mineral density of HIV-infected children when compared to HIV-exposed but uninfected children and to identify factors contributing to abnormal bone mineralization.
Neurologic, neurodevelopment, language, and behavioral function:

To examine cognitive and behavioral outcomes of HIV-infected children and adolescents, including high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use, neurodevelopmental impairment, school achievement and to compare them with an HIV-exposed but uninfected control cohort.
To examine non-adherence to antiretroviral therapy and predictors of non-adherence among HIV-infected children receiving ART.
To examine family and psychosocial factors associated with emotional and behavioral problems.

Adolescent gynecology and STI infection:

To evaluate the incidence of and risk factors for acquiring STIs/vaginal infections (C. trachomatis, N. gonorrhea, T. vaginalis, syphilis, genital warts, HPV, and HSV) for males and females, and in addition bacterial vaginosis for females.
To evaluate the incidence, predictors, and outcomes of pregnancy.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Infected Cohort	–	–Perinatally HIV-infected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment, engaged in care with ART treatment history available.
Uninfected Cohort	–	–HIV-uninfected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment born to HIV-infected mothers.

Who may qualify

Ages: 7 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: HIV-infected and -uninfected children from 7 years of age (7th birthday) up to but not including the 16th birthday at the time of enrollment born to HIV-infected mothers. Participants will be children previously enrolled in any of the studies included on the list of approved studies for co-enrollment (see below) or has medical record documentation since birth of key medical data related to their HIV infection.

Key inclusion criteria (11 listed)

Perinatal HIV infection as documented in the medical record.
Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
Engaged in care and ART history is available.
Either: Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP as specified in the protocol. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols are listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history 2)Opportunistic Infection (OI) prophylaxis exposure history 3) Viral load and CD4 count history and 4) Major medical events history
Willingness to participate and provide parental/legal guardian permission with assent. Children who do not know their HIV infection status will not be excluded.

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.

Primary outcome

Abnormal growth
Time frame: Annually for 10 years
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.
Delayed sexual maturation
Time frame: Annually for 10 years except if subject reaches Tanner Stage 5
Assessed via tanner staging; subjects meeting the growth trigger based on the results of the tanner staging will also have the following laboratory assessments: morning LH, FSH, estradiol, and testosterone
Abnormal bone mineral density
Time frame: Two DXAs, two years apart, per HIV-infected subject; one DXA per uninfected subject; X-ray at same time as DXA unless subject Tanner Stage 5
Assessed via DXA scan and x-ray for bone age; subjects meeting the BMD trigger based on the DXA also have the following laboratory assessments: TSH, calcium, 25-hydroxy-vitamin D, bone-specific alkaline, N-terminal telopeptide of type I collagen phosphatase, and PTH in real time and repository specimens for assay of pro-inflammatory cytokines (IL-1, IL-6, TNF-a)
Dyslipidemia
Time frame: Annually for 10 years
Assessed via lipid testing; subjects meeting the metabolic trigger based on the results of the lipid tests also have the following measurements: endothelial dysfunction (I, E, P-selectins: V, I-CAM-1, endothelin-1, hs-CRP, homocysteine, apolipoprotein B, lipoprotein (a), and vWF antigen)
Cardiac abnormalities
Time frame: Measured once per subject until study reached 400 echocardiograms
Assessed through the administration of echocardiograms and serum biomarkers (ProBNP)
Hearing dysfunction
Time frame: Once per subject.
Assessed via audiologic evaluation conducted by an audiologist.
Language dysfunction
Time frame: Annually for 10 years
Assessed using the Woodcock and CELF IV language tests
Neurodevelopmental abnormalities
Time frame: Annually for 10 years
Assessed via the following neurodevelopmental tests: WISC IV, WAIS IV, BRIEF, Children's Color Trails Test, Trail Making Tests, WIAT-II screen, ABAS, Parent Child Relationship Inventory, BASC-2, Quality of Life Interview, Stressful Life Events Questionnaire, Monitoring the Future
Substance Use
Time frame: Annually starting at a minimum of 10 years of age for 10 years
The assessment of sexual activity is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.
Sexual Activity
Time frame: Annually starting at a minimum of 10 years of age for 10 years
The assessment of substance use is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.
Pregnancy
Time frame: Annually for 10 years
Assessed via medical record review to record incidents of pregnancy
Sexually Transmitted Infection
Time frame: Annually for 10 years
Assessed via medical record review to record results of clinically conducted STI and Pap testing and pelvic exams
Mitochondrial dysfunction
Time frame: Annually for 10 years
Assessed via measurement of serum lactate levels, OXPHO immunoassays, mitochondrial specific oxidative stress, mtDNA copies/cell, mrRNA transcripts
Lactic acidosis
Time frame: Annually for 10 years
Assessed through the measurement of blood lactate levels using a point-of-care lactate measuring device; a single venous lactate measurement will be conducted in cases where the POC lactate measure is elevated
Renal abnormalities
Time frame: Annually for 10 years
Assessed through the following laboratory measurements: chemistry panel, urinalysis, protein/creatinine ratio, dip stick urine test

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 27 Jun 2025.
Results publication: PubMed 20539091Kapetanovic S, Leister E, Nichols S, Miller T, Tassiopoulos K, Hazra R, Gelbard HA, Malee KM, Kammerer B, Mendez AJ, Williams PL; Pediatric HIV/AIDS Cohort Study Team. Relationships between markers of vascular dysfunction and neurodevelopmental outcomes in perinatally HIV-infected youth. AIDS. 2010 Jun 19;24(10):1481-91. doi: 10.1097/QAD.0b013e32833a241b.
Results publication: PubMed 21407086Van Dyke RB, Patel K, Siberry GK, Burchett SK, Spector SA, Chernoff MC, Read JS, Mofenson LM, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Antiretroviral treatment of US children with perinatally acquired HIV infection: temporal changes in therapy between 1991 and 2009 and predictors of immunologic and virologic outcomes. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):165-73. doi: 10.1097/QAI.0b013e318215c7b1.
Results publication: PubMed 21423022Siberry GK, Patel K, Van Dyke RB, Hazra R, Burchett SK, Spector SA, Paul ME, Read JS, Wiznia A, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study(PHACS). CD4+ lymphocyte-based immunologic outcomes of perinatally HIV-infected children during antiretroviral therapy interruption. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):223-9. doi: 10.1097/QAI.0b013e318218e068.
Results publication: PubMed 21702707Malee KM, Tassiopoulos K, Huo Y, Siberry G, Williams PL, Hazra R, Smith RA, Allison SM, Garvie PA, Kammerer B, Kapetanovic S, Nichols S, Van Dyke R, Seage GR 3rd, Mellins CA; Pediatric HIV/AIDS Cohort Study Team. Mental health functioning among children and adolescents with perinatal HIV infection and perinatal HIV exposure. AIDS Care. 2011 Dec;23(12):1533-44. doi: 10.1080/09540121.2011.575120.
Results publication: PubMed 21992620Mellins CA, Tassiopoulos K, Malee K, Moscicki AB, Patton D, Smith R, Usitalo A, Allison SM, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Behavioral health risks in perinatally HIV-exposed youth: co-occurrence of sexual and drug use behavior, mental health problems, and nonadherence to antiretroviral treatment. AIDS Patient Care STDS. 2011 Jul;25(7):413-22. doi: 10.1089/apc.2011.0025. Epub 2011 May 5.
Results publication: PubMed 22042056Geffner ME, Patel K, Miller TL, Hazra R, Silio M, Van Dyke RB, Borkowsky W, Worrell C, DiMeglio LA, Jacobson DL; Pediatric HIV/AIDS Cohort Study. Factors associated with insulin resistance among children and adolescents perinatally infected with HIV-1 in the pediatric HIV/AIDS cohort study. Horm Res Paediatr. 2011;76(6):386-91. doi: 10.1159/000332957. Epub 2011 Oct 26.
Results publication: PubMed 22049166Jacobson DL, Patel K, Siberry GK, Van Dyke RB, DiMeglio LA, Geffner ME, Chen JS, McFarland EJ, Borkowsky W, Silio M, Fielding RA, Siminski S, Miller TL; Pediatric HIV/AIDS Cohort Study. Body fat distribution in perinatally HIV-infected and HIV-exposed but uninfected children in the era of highly active antiretroviral therapy: outcomes from the Pediatric HIV/AIDS Cohort Study. Am J Clin Nutr. 2011 Dec;94(6):1485-95. doi: 10.3945/ajcn.111.020271. Epub 2011 Nov 2.
Results publication: PubMed 22136114Miller TI, Borkowsky W, DiMeglio LA, Dooley L, Geffner ME, Hazra R, McFarland EJ, Mendez AJ, Patel K, Siberry GK, Van Dyke RB, Worrell CJ, Jacobson DL; Pediatric HIV/AIDS Cohort Study (PHACS); Shearer W, Cooper N, Harris L, Purswani M, Baig M, Cintron A, Puga A, Navarro S, Patton D, Burchett S, Karthas N, Kammerer B, Yogev R, Malee K, Hunter S, Cagwin E, Wiznia A, Burey M, Nozyce M, Chen J, Gobs E, Grant M, Knapp K, Allison K, Garvie P, Acevedo-Flores M, Rios H, Olivera V, Silio M, Borne C, Sirois P, Spector S, Norris K, Nichols S, McFarland E, Barr E, Chambers C, Watson D, Messenger N, Belanger R, Dieudonne A, Bettica L, Adubato S, Scott G, Himic L, Willen E. Metabolic abnormalities and viral replication are associated with biomarkers of vascular dysfunction in HIV-infected children. HIV Med. 2012 May;13(5):264-75. doi: 10.1111/j.1468-1293.2011.00970.x. Epub 2011 Dec 4.
Results publication: PubMed 22549437Torre P 3rd, Zeldow B, Hoffman HJ, Buchanan A, Siberry GK, Rice M, Sirois PA, Williams PL; Pediatric HIVAIDS Cohort Study. Hearing loss in perinatally HIV-infected and HIV-exposed but uninfected children and adolescents. Pediatr Infect Dis J. 2012 Aug;31(8):835-41. doi: 10.1097/INF.0b013e31825b9524.
Results publication: PubMed 22179050Rice ML, Buchanan AL, Siberry GK, Malee KM, Zeldow B, Frederick T, Purswani MU, Hoffman HJ, Sirois PA, Smith R, Torre P 3rd, Allison SM, Williams PL. Language impairment in children perinatally infected with HIV compared to children who were HIV-exposed and uninfected. J Dev Behav Pediatr. 2012 Feb;33(2):112-23. doi: 10.1097/DBP.0b013e318241ed23.
Results publication: PubMed 22094294Siberry GK, Leister E, Jacobson DL, Foster SB, Seage GR 3rd, Lipshultz SE, Paul ME, Purswani M, Colin AA, Scott G, Shearer WT. Increased risk of asthma and atopic dermatitis in perinatally HIV-infected children and adolescents. Clin Immunol. 2012 Feb;142(2):201-8. doi: 10.1016/j.clim.2011.10.005. Epub 2011 Oct 30.
Results publication: PubMed 22592486Smith R, Chernoff M, Williams PL, Malee KM, Sirois PA, Kammerer B, Wilkins M, Nichols S, Mellins C, Usitalo A, Garvie P, Rutstein R; Pediatric HIV/AIDS Cohort Study (PHACS) Team. Impact of HIV severity on cognitive and adaptive functioning during childhood and adolescence. Pediatr Infect Dis J. 2012 Jun;31(6):592-8. doi: 10.1097/INF.0b013e318253844b.
Pediatric HIV/AIDS Cohort StudyLink 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.

Paige L Williams principal investigator

Harvard School of Public Health (HSPH)

Russell Van Dyke, M.D. principal investigator

Tulane University School of Medicine

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 15 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 11 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: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

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?

Abnormal growth (time frame: Annually for 10 years). The study lists 15 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 NCT01418014, which also lists 112 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 27 Jun 2025.