Long-Term Effects of HIV Exposure and Infection in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006304
First received: September 27, 2000
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

As new drugs and vaccines are developed to prevent HIV disease progression and prolong survival of HIV infected patients, the short-term safety and effectiveness of these treatments are evaluated in research studies. However, the long-term effects, whether they are benefits or side effects, need to be studied as well. These long-term effects may have a greater impact on infants and children who are still growing and developing. The purpose of this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be observed for long-term benefits or any late harmful effects of medications or vaccines.


Condition
HIV Infections
HIV Seronegativity

Study Type: Observational
Official Title: Pediatric Late Outcomes Protocol

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 4150
Study Completion Date: May 2002
Detailed Description:

The potential long-term benefits, toxicities, and other adverse outcomes of new anti-HIV therapies cannot be assessed within the time frame of most clinical trials. There is a need to better assess both positive and negative late outcomes and late treatment effects in growing children. This prospective, longitudinal study will evaluate the effects and their impact on children.

Children in this study will include patients who are HIV infected, were exposed to HIV or anti-HIV drugs prior to or at the time of their birth, or children of patients followed at Pediatric AIDS Clinical Trial Group (PACTG) sites. Children will have a study visit every 3 months through the first year of life. After age 1, children who are HIV infected will continue to have study visits every 3 months, while children who are HIV uninfected will have study visits once a year. Study assessments will include complete physical exam, medical history, Tanner staging, neurologic exam, growth and quality of life assessments, and laboratory tests such as hematology, chemistries, and urinalysis. Not all assessments will be performed at each study visit. Patients will be followed until age 24.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Age 21 or younger (consent of parent or guardian required if under 18).
  • Meet 1 of the following 3 requirements: 1) enrolled in a previous version of this study; 2) perinatally exposed to HIV, HIV vaccines, or antiretroviral treatment (must enroll before first birthday); 3) HIV infected infants, children, and adolescents (and their offspring) followed at PACTG sites.

Exclusion Criteria

  • Unable to adhere to study visit schedules.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006304

  Show 92 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: James Oleske
Study Chair: Michael Brady
Study Chair: Wayne Dankner
  More Information

Additional Information:
Publications:
Brady MT, Clark C, Weedy C, Fowler M, Mofenson L, Oleske J. Disclosure of HIV diagnosis to children in ACTG clinical trials (ACTG 219). Int Conf AIDS. 1996 Jul 7-12;11(2):43 (abstract no WeD131)
Gaughan DM, Mofeson LM, Hughes MD, Seage GR, Oleske JM. Avascular necrosis of the hip (Leggs-Calve-Perthes disease [LCPD]) in HIV-infected children in long-term follow-up: PACTG study 219. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 638)
Moye J, Cervia J, Lindsey JC, Hughes MD, Seage G, Dankner W, Oleske J. Impact of protease inhibitor (PI)-containing combination antiretroviral therapies on height and weight growth in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 515)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006304     History of Changes
Obsolete Identifiers: NCT00000786
Other Study ID Numbers: ACTG 219C, ACTG 219, PACTG 219C, 11196
Study First Received: September 27, 2000
Last Updated: October 4, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014