HIVNCT00339612
NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
An observational study of HIV, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 14 sites in 3 countries.
Trial summary
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- HIV
- How many people
- 2,129 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 30 Jul 2002to 28 Jul 2020
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
Who may be able to join
- Static Cohort:
- Previous participation in a NISDI Protocol
- Less then 6 years of age (before their 6th birthday) at the time of enrollment into the NISDI Pediatric Protocol
- HIV-infected
- HIV infection must be documented in the medical records by:
- For children less than 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
Show all 38Show fewer
- Positive HIV culture
- Positive HIV DNA PCR
- Positive neutralizable p24 antigen
- Quantitative HIV RNA greater than or equal to 10,000 copies/ml
- For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
- Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay
- Positive HIV culture
- Positive HIV DNA PCR
- Positive neutralizable p24 antigen
- Quantitative HIV RNA greater than or equal to 1,000 copies/ml
- Documentation of maternal HIV infection by country appropriate National Guidelines
- Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.
- Subjects must be able to be followed at a participating clinical site.
- Subjects may be co-enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV-related effects.
- Dynamic cohort:
- HIV-infected less then 6 years of age (before their 6th birthday) at enrollment into this protocol
- HIV infection documented by:
- For children <18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
- Positive HIV culture
- Positive HIV DNA PCR
- Positive neutralizable p24 antigen
- Quantitative HIV RNA greater than or equal to 10,000 copies/ml
- For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
- Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay
- Positive HIV culture
- Positive HIV DNA PCR
- Positive neutralizable p24 antigen
- Quantitative HIV RNA greater than or equal to 1,000 copies/ml
- Documentation of maternal HIV infection by country appropriate National Guidelines
- Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.
- Subjects must be able to be followed at a participating clinical site
- Subjects may be co enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV related effects
Who cannot join
- Children who are born to an HIV infected mother, but are uninfected or of indeterminate HIV infection status
- Children who are orphans without legal guardians or are wards of the state
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Brazil12 sites
Universidade Federal de Minas Gerais
Belo Horizonte
Ricardo de Souza STD/HIV Clinic-Caxias do Sul
Caxias do Sul
Hospital Conceicao
Porto Alegre
Hospital de Clinicas
Porto Alegre
Hospital Femina
Porto Alegre
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Hospital dos Servidores do Estado
Rio de Janeiro
Hospital Geral Nova de Iguacu
Rio de Janeiro
Instituto de Puericultura e Pediatria Martagao Gesteira
Rio de Janeiro
Federal University of Sao Paulo-Escola Paulista de Medicina
São Paulo
Hospital das Clinicas da Falculdade De Medinica
São Paulo
Instituto de Infectologica Emilio Ribas (IIER)
São Paulo
About this study
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
Read the detailed description
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
- Conditions
- HIV
- Keywords
- Perinatal, 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 group | Role | What they receive |
|---|---|---|
| HIV-infected children who acquired HIV infection through mothe | HIV-infected children in who acquired HIV infection through mother-to-child transmission (MTCT). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start30 Jul 2002
- Primary completion30 Dec 2011
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- 2,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rohan Hazra, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339612
- Sponsor's protocol ID
- 999902270
- Other IDs
- 02-CH-N270
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2006
- Last updated
- 30 Jul 2020
- Results posted
- No
Publications
Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
PubMed 7935654Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French PT, Wang L, Baum JB, Tesoriero JM, Savicki R. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med. 1998 Nov 12;339(20):1409-14. doi: 10.1056/NEJM199811123392001.
PubMed 9811915Lindegren ML, Byers RH Jr, Thomas P, Davis SF, Caldwell B, Rogers M, Gwinn M, Ward JW, Fleming PL. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA. 1999 Aug 11;282(6):531-8. doi: 10.1001/jama.282.6.531.
PubMed 10450714
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
- ClinicalTrials.gov ID
- NCT00339612
- Acronym / sponsor ID
- 999902270
- Conditions
- HIV
- Keywords
- Perinatal, HIV, AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,129 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 30 Jul 2002 (actual)
- Primary completion
- 30 Dec 2011 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 21 Jun 2006 (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.
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
Detailed description
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries. Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected children who acquired HIV infection through mothe | – | –HIV-infected children in who acquired HIV infection through mother-to-child transmission (MTCT). |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission (MTCT). The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol. The second cohort will be a dynamic cohort of prospectively enrolled, HIV-infected children who are five years of age or younger. We will characterize complications from both the disease and its treatments. Subjects will be evaluated every six months for approximately five years and assessments of growth, morbidity, disease progression and mortality will be made.
Key inclusion criteria (38 listed)
- Previous participation in a NISDI Protocol
- Less then 6 years of age (before their 6th birthday) at the time of enrollment into the NISDI Pediatric Protocol
- HIV-infected
- HIV infection must be documented in the medical records by:
- Documentation of maternal HIV infection by country appropriate National Guidelines
Key exclusion criteria (2 listed)
- Children who are born to an HIV infected mother, but are uninfected or of indeterminate HIV infection status
- Children who are orphans without legal guardians or are wards of the state
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
Not reported in the source record.
4 secondary outcomes
HIV RNA copies
Time frame: q 6 months
CD4 + T cell count
Time frame: q 6 months
medical history
Time frame: q 6 months
hematology and chemistry labs
Time frame: q 6 months
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 30 Jul 2020.
- Background: PubMed 7935654Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
- Background: PubMed 9811915Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French PT, Wang L, Baum JB, Tesoriero JM, Savicki R. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med. 1998 Nov 12;339(20):1409-14. doi: 10.1056/NEJM199811123392001.
- Background: PubMed 10450714Lindegren ML, Byers RH Jr, Thomas P, Davis SF, Caldwell B, Rogers M, Gwinn M, Ward JW, Fleming PL. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA. 1999 Aug 11;282(6):531-8. doi: 10.1001/jama.282.6.531.
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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.
Rohan Hazra, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 14 sites in 3 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 38 inclusion and 2 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil, Mexico, Peru. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339612, which also lists 3 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 30 Jul 2020.