This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. HIV infection is a significant risk factor for HPV infection and the development of HPV-associated diseases. Today, treatment with HART has been demonstrated to result in significant increase in CD 4 cell counts and partial reconstitution of the immune system. A5029 is an observational, multicenter, prospective study designed to assess the conversion rate of HPV DNA among those HIV-infected subjects who have responded to HAART with suppressed HIV-1 RNA levels after 48 weeks. The study population includes antiretroviral-naive, HIV-infected, post-menarche females. Pap smears and other study data will be obtained prospectively from subjects at baseline, weeks 24,48 and every 48 weeks thereafter. The study will extend for 144 weeks after accrual of the last subject. A total of 160 subjects who are HIV-infected, antiretroviral naive, post-menarche females >13 years of age with 14 days of antiretroviral therapy at any time since HIV diagnosis will be enrolled. Subjects must be coenrolled in an approved Haart treatment trial, Phase II or higher, and will remain on A5029 even if they withdraw from the antiretroviral trial, as long as the antiretroviral trial HAART treatment was begun.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000750-34
Application #
7379061
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
34
Fiscal Year
2006
Total Cost
$2,193
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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