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Long-Term Effects of HIV Exposure and Infection in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006304
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 7, 2013
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease
HIV Infections HIV Seronegativity

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.

Study Type : Observational
Estimated Enrollment : 4150 participants
Official Title: Pediatric Late Outcomes Protocol
Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006304

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Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: James Oleske
Study Chair: Michael Brady
Study Chair: Wayne Dankner

Publications of Results:

Other 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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00006304     History of Changes
Obsolete Identifiers: NCT00000786
Other Study ID Numbers: ACTG 219C
ACTG 219
11196 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: October 2013

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

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