Long-Term Effects of HIV Exposure and Infection in Children
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ClinicalTrials.gov Identifier: NCT00006304 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: October 7, 2013
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Condition or disease |
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HIV Infections HIV Seronegativity |
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 |
Enrollment : | 4150 participants |
Official Title: | Pediatric Late Outcomes Protocol |
Actual Study Completion Date : | May 2002 |


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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00006304

Study Chair: | James Oleske | ||
Study Chair: | Michael Brady | ||
Study Chair: | Wayne Dankner |
Publications of Results:
Other Publications:
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 ( 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:
Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |