Updated Information and Clarification: RFA-HD-05-018 Pediatric HIV/AIDS Cohort Study (PHACS)

Notice Number: NOT-HD-05-008

Key Dates
Release Date: February 16, 2005

Issued by
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)

The Pediatric HIV/AIDS Cohort Study (PHACS) is cosponsored by NICHD, NIAID, NIDA, and NIMH.

The PHACS was designed to address two objectives, as described in the RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-05-018.html):

The purpose of this notice is to provide (a) additional explanation about potential collaborations with the CDC LEGACY ("Longitudinal Epidemiologic Study to Gain Insight into HIV and AIDS in Children and Youth”) and (b) clarification of the fact that monitoring complications of antiretroviral treatment in perinatally HIV-infected children may be included as part of the objectives of PHACS.

(a) Potential Collaborations with LEGACY

In phase 1, PHACS is soliciting a leadership group and a data center to develop the research agenda to address these questions, to establish the base protocols, and to plan collaborations with other federally funded cohorts, such as the CDC LEGACY.

The CDC LEGACY project is a chart-review-based follow-up of HIV-infected children at approximately 20 sites in the U.S. PHACS, as currently planned, does not have resources to intensively monitor large numbers of infected children for potential late complications of treatment. However, the PHACS collaboration may, to the extent resources permit, include a LEGACY-like record review for HIV-infected children at PHACS sites that are not participating in the LEGACY project.

(b) Monitoring Complications of Antiretroviral Treatment

To address questions of importance on toxicities and complications of therapy where sample size would require collaboration with other studies, the PHACS would anticipate collaboration with LEGACY (and/or other domestic cohorts), and the combined cohorts could be used to detect potential "signals" of drug toxicity in HIV-infected children. Targeted studies then could be developed by investigators in PHACS, LEGACY, or other groups, to address specific questions related to late toxicity in the infected child cohorts.

In phase 2, PHACS will solicit sites. Sites can be subcontracted to address question 1 or question 2 or both. Site selection will be independent of site selection for the DAIDS clinical trial networks. There is no intention by PHACS to provide a protocol to replace the current Pediatric AIDS Clinical Trials Group protocol 219C (“Late Outcomes Protocol)”) for DAIDS-funded pediatric clinical trials sites, although it is possible that sites funded by PHACS may also be funded by DAIDS as part of a clinical trials network. It is expected by NIH that activities of PHACS and any pediatric network funded by DAIDS would be fully coordinated to avoid duplication and to maximize efficiency through collaboration.

The initial focus of PHACS will be on domestic pediatric populations. PHACS was not intended to nor does it have resources to provide funding for similar cohorts on an international basis. However, after the domestic protocol has been initiated, it is expected that PHACS will provide consultation for the development of international protocols to address similar questions, and will coordinate its activities with future international efforts supported by DAIDS-funded clinical trials groups.

Inquiries

For questions or further information, contact:

Jack Moye, M.D.
Pediatric, Adolescent, and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda MD 20892-7510
Phone: (301) 496-7350
FAX: (301) 496-8678
E-mail: moyej@mail.nih.gov


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