Cardiovascular DiseasesCHAART-1NCT00253682
Effects of Highly Active Anti-Retroviral Therapy on Cardiovascular Health in Infants of HIV-Infected Mothers
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Miami at 5 sites in United States.
Trial summary
This study will determine the impact of highly active antiretroviral therapy (HAART) on the developing cardiovascular system, the evolution of HAART-associated cardiovascular changes over time, and the association between cardiovascular measurements with HAART exposure. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis
- How many people
- 167 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2002to Dec 2006
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS). The comparison group will be a historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART.
Who may be able to join
- Children who are actively enrolled in the WITS study, regardless of whether or not they have been exposed to HAART therapy
- Children enrolled into this study from one of the designated WITS clinical sites
- Mothers or legal guardians understand and are willing to provide informed consent with or without the help of an interpreter
Who cannot join
- Children diagnosed with HIV infection
- Mother has maternal diabetes or phenylketonuria
- Mother has been told by a physician that she has chromosomal defects
- Mother has functional heart defects that have required medications or surgeries
- Mother received cancer chemotherapy or radiation therapy during pregnancy
- Mother used lithium carbonate, anticonvulsants, amphetamines, or angiotensin converting enzyme (ACE) inhibitors during pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Illinois - Chicago
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
University of Miami School of Medicine
Miami, Florida, 33101
Columbia University
New York, New York, 10027
About this study
Official title: Cardiac Status of HAART Exposed Infants of HIV-Infected Mothers (CHAART I)
This study will determine the impact of highly active antiretroviral therapy (HAART) on the developing cardiovascular system, the evolution of HAART-associated cardiovascular changes over time, and the association between cardiovascular measurements with HAART exposure.
Read the detailed description
BACKGROUND:
HIV-infected pregnant women frequently receive HAART, which is associated with reduced maternal-fetal transmission of HIV infection. This has resulted in a rapidly increasing number of seroreverters (HIV-uninfected infants born to HIV-infected women), representing the majority of infants in the United States exposed to HAART. Long-term consequences and toxicities associated with this exposure are not known, but severe cardiotoxicity is suggested in animal models. This study will utilize HIV seroreverter cohorts from the NIH-sponsored Women and Infants Transmission Study (WITS) and Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infections Study (P2C2) to determine how left ventricular (LV) structure and function, serum cardiac troponin T (cTnT), serum pro brain natriuretic peptide (proBNP), and serum high sensitivity C reactive protein (hsCRP) are affected by HAART exposure. In P2C2, patients were recruited from May 1990 to January 1994 from five clinical centers in the United States.
This study was initiated in 2002 in response to a 'Request for Applications' on HAART cardiovascular toxicities.
DESIGN NARRATIVE:
This study will utilize HIV seroreverter cohorts from the NIH-sponsored WITS and P2C2 cohorts to determine how LV structure and function, cTnT, proBNP, and hsCRP are affected by HAART exposure. The p2C2 seroreverter cohort has been exposed to no antiretroviral therapy or zidovudine alone (without HAART) and has persistent significantly depressed LV contractility in comparison to normal with up to 5 years of follow-up. The WITS seroreverter cohort has been exposed mostly to HAART. This cohort will determine the incremental effect of HAART on LV structure and function by following the P2C2 protocol for assessment of LV structure and function. This study will test three hypotheses: 1) that HAART exposure results in fetal and neonatal myocardiocyte injury and death (by serial assessment of cTnT [a biomarker of acute myocardial injury] in both seroreverter cohorts); 2) that HAART exposure results in impaired myocardiocyte mitochondrial function resulting in LV dysfunction (by serial assessment of proBNP [a biomarker related to LV dysfunction], LV volume and pressure increases resulting in LV stretch, and neurohormonal activation); and 3) that HAART exposure results in accelerated atherosclerosis (by serial assessment of hsCRP [a biomarker of generalized inflammation predictive of increased subsequent coronary artery disease]). This study will determine the cardiovascular effects of HAART in seroreverters and the need for future cardiovascular follow-up and cardiovascular preventive and therapeutic trials in this rapidly expanding population.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, HIV Infections, Cardiomyopathy, Hypertrophic
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, HIV Infections, Cardiomyopathy, Hypertrophic
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 |
|---|---|---|
| 1 | HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS). | |
| 2 | Historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startSep 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor College of Medicine, University of Illinois Chicago, Clinical Trials & Surveys Corp (C-TASC), Columbia University, Boston Medical Center
- Responsible party
- Principal investigator, Steven E. Lipshultz, MD, University of Miami
- Investigators
- Steven E. Lipshultz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253682
- Sponsor's protocol ID
- 342
- Other IDs
- R01HL072705
- Acronym
- CHAART-1
- Status last verified
- Mar 2014
- First submitted
- 10 Nov 2005
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seeborg FO, Gay H, Schmiege LM 3rd, Bernard D, Shearer WT. Immunoglobulin G kappa [IgG kappa] and IgG lambda paraproteinemia in a child with AIDS and response to highly active antiretroviral therapy. Clin Diagn Lab Immunol. 2005 Nov;12(11):1331-3. doi: 10.1128/CDLI.12.11.1331-1333.2005.
PubMed 16275950Shearer WT. Infection versus immunity: What's the balance? J Allergy Clin Immunol. 2005 Aug;116(2):263-6. doi: 10.1016/j.jaci.2005.06.001. No abstract available.
PubMed 16083777Simbre VC, Duffy SA, Dadlani GH, Miller TL, Lipshultz SE. Cardiotoxicity of cancer chemotherapy: implications for children. Paediatr Drugs. 2005;7(3):187-202. doi: 10.2165/00148581-200507030-00005.
PubMed 15977964Lipshultz SE, Lipsitz SR, Sallan SE, Dalton VM, Mone SM, Gelber RD, Colan SD. Chronic progressive cardiac dysfunction years after doxorubicin therapy for childhood acute lymphoblastic leukemia. J Clin Oncol. 2005 Apr 20;23(12):2629-36. doi: 10.1200/JCO.2005.12.121.
PubMed 15837978Moylett EH, Hanson IC. Mechanistic actions of the risks and adverse events associated with vaccine administration. J Allergy Clin Immunol. 2004 Nov;114(5):1010-20; quiz 1021. doi: 10.1016/j.jaci.2004.09.007.
PubMed 15536401Shearer WT. Importance of technology for the future of allergy and immunology. J Allergy Clin Immunol. 2004 Aug;114(2):406-8. doi: 10.1016/j.jaci.2004.06.031. No abstract available.
PubMed 15316524Seeborg FO, Paul ME, Abramson SL, Kearney DL, Dorfman SR, Holland SM, Shearer WT. A 5-week-old HIV-1-exposed girl with failure to thrive and diffuse nodular pulmonary infiltrates. J Allergy Clin Immunol. 2004 Apr;113(4):627-34. doi: 10.1016/j.jaci.2004.01.763.
PubMed 15100665Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69.
PubMed 15060200Nance CL, Shearer WT. Is green tea good for HIV-1 infection? J Allergy Clin Immunol. 2003 Nov;112(5):851-3. doi: 10.1016/j.jaci.2003.08.048. No abstract available.
PubMed 14610469Al-Attar I, Orav EJ, Exil V, Vlach SA, Lipshultz SE. Predictors of cardiac morbidity and related mortality in children with acquired immunodeficiency syndrome. J Am Coll Cardiol. 2003 May 7;41(9):1598-605. doi: 10.1016/s0735-1097(03)00256-0.
PubMed 12742303
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Status of HAART Exposed Infants of HIV-Infected Mothers (CHAART I)
- ClinicalTrials.gov ID
- NCT00253682
- Acronym / sponsor ID
- CHAART-1 / 342
- Conditions
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, HIV Infections, Cardiomyopathy, Hypertrophic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor College of Medicine, University of Illinois Chicago, Clinical Trials & Surveys Corp (C-TASC), Columbia University, Boston Medical Center
- Study start
- Sep 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Nov 2005 (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 study will determine the impact of highly active antiretroviral therapy (HAART) on the developing cardiovascular system, the evolution of HAART-associated cardiovascular changes over time, and the association between cardiovascular measurements with HAART exposure.
Detailed description
BACKGROUND:
HIV-infected pregnant women frequently receive HAART, which is associated with reduced maternal-fetal transmission of HIV infection. This has resulted in a rapidly increasing number of seroreverters (HIV-uninfected infants born to HIV-infected women), representing the majority of infants in the United States exposed to HAART. Long-term consequences and toxicities associated with this exposure are not known, but severe cardiotoxicity is suggested in animal models. This study will utilize HIV seroreverter cohorts from the NIH-sponsored Women and Infants Transmission Study (WITS) and Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infections Study (P2C2) to determine how left ventricular (LV) structure and function, serum cardiac troponin T (cTnT), serum pro brain natriuretic peptide (proBNP), and serum high sensitivity C reactive protein (hsCRP) are affected by HAART exposure. In P2C2, patients were recruited from May 1990 to January 1994 from five clinical centers in the United States.
This study was initiated in 2002 in response to a 'Request for Applications' on HAART cardiovascular toxicities.
DESIGN NARRATIVE:
This study will utilize HIV seroreverter cohorts from the NIH-sponsored WITS and P2C2 cohorts to determine how LV structure and function, cTnT, proBNP, and hsCRP are affected by HAART exposure. The p2C2 seroreverter cohort has been exposed to no antiretroviral therapy or zidovudine alone (without HAART) and has persistent significantly depressed LV contractility in comparison to normal with up to 5 years of follow-up. The WITS seroreverter cohort has been exposed mostly to HAART. This cohort will determine the incremental effect of HAART on LV structure and function by following the P2C2 protocol for assessment of LV structure and function. This study will test three hypotheses: 1) that HAART exposure results in fetal and neonatal myocardiocyte injury and death (by serial assessment of cTnT [a biomarker of acute myocardial injury] in both seroreverter cohorts); 2) that HAART exposure results in impaired myocardiocyte mitochondrial function resulting in LV dysfunction (by serial assessment of proBNP [a biomarker related to LV dysfunction], LV volume and pressure increases resulting in LV stretch, and neurohormonal activation); and 3) that HAART exposure results in accelerated atherosclerosis (by serial assessment of hsCRP [a biomarker of generalized inflammation predictive of increased subsequent coronary artery disease]). This study will determine the cardiovascular effects of HAART in seroreverters and the need for future cardiovascular follow-up and cardiovascular preventive and therapeutic trials in this rapidly expanding population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS). |
| 2 | – | –Historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS). The comparison group will be a historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART.
Key inclusion criteria (3 listed)
- Children who are actively enrolled in the WITS study, regardless of whether or not they have been exposed to HAART therapy
- Children enrolled into this study from one of the designated WITS clinical sites
- Mothers or legal guardians understand and are willing to provide informed consent with or without the help of an interpreter
Key exclusion criteria (6 listed)
- Children diagnosed with HIV infection
- Mother has maternal diabetes or phenylketonuria
- Mother has been told by a physician that she has chromosomal defects
- Mother has functional heart defects that have required medications or surgeries
- Mother received cancer chemotherapy or radiation therapy during pregnancy
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.
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 18 Mar 2014.
- Background: PubMed 16275950Seeborg FO, Gay H, Schmiege LM 3rd, Bernard D, Shearer WT. Immunoglobulin G kappa [IgG kappa] and IgG lambda paraproteinemia in a child with AIDS and response to highly active antiretroviral therapy. Clin Diagn Lab Immunol. 2005 Nov;12(11):1331-3. doi: 10.1128/CDLI.12.11.1331-1333.2005.
- Background: PubMed 16083777Shearer WT. Infection versus immunity: What's the balance? J Allergy Clin Immunol. 2005 Aug;116(2):263-6. doi: 10.1016/j.jaci.2005.06.001. No abstract available.
- Background: PubMed 15977964Simbre VC, Duffy SA, Dadlani GH, Miller TL, Lipshultz SE. Cardiotoxicity of cancer chemotherapy: implications for children. Paediatr Drugs. 2005;7(3):187-202. doi: 10.2165/00148581-200507030-00005.
- Background: PubMed 15837978Lipshultz SE, Lipsitz SR, Sallan SE, Dalton VM, Mone SM, Gelber RD, Colan SD. Chronic progressive cardiac dysfunction years after doxorubicin therapy for childhood acute lymphoblastic leukemia. J Clin Oncol. 2005 Apr 20;23(12):2629-36. doi: 10.1200/JCO.2005.12.121.
- Background: PubMed 15536401Moylett EH, Hanson IC. Mechanistic actions of the risks and adverse events associated with vaccine administration. J Allergy Clin Immunol. 2004 Nov;114(5):1010-20; quiz 1021. doi: 10.1016/j.jaci.2004.09.007.
- Background: PubMed 15316524Shearer WT. Importance of technology for the future of allergy and immunology. J Allergy Clin Immunol. 2004 Aug;114(2):406-8. doi: 10.1016/j.jaci.2004.06.031. No abstract available.
- Background: PubMed 15100665Seeborg FO, Paul ME, Abramson SL, Kearney DL, Dorfman SR, Holland SM, Shearer WT. A 5-week-old HIV-1-exposed girl with failure to thrive and diffuse nodular pulmonary infiltrates. J Allergy Clin Immunol. 2004 Apr;113(4):627-34. doi: 10.1016/j.jaci.2004.01.763.
- Background: PubMed 15060200Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69.
- Background: PubMed 14610469Nance CL, Shearer WT. Is green tea good for HIV-1 infection? J Allergy Clin Immunol. 2003 Nov;112(5):851-3. doi: 10.1016/j.jaci.2003.08.048. No abstract available.
- Background: PubMed 12742303Al-Attar I, Orav EJ, Exil V, Vlach SA, Lipshultz SE. Predictors of cardiac morbidity and related mortality in children with acquired immunodeficiency syndrome. J Am Coll Cardiol. 2003 May 7;41(9):1598-605. doi: 10.1016/s0735-1097(03)00256-0.
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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.
Steven E. Lipshultz, MD principal investigator
University of Miami
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Miami at 5 sites in United States.
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 3 inclusion and 6 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 NCT00253682, 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 18 Mar 2014.