Abstract

This application was submitted by investigators in the area of HIV-1 perinatal transmission research from Johns Hopkins University and Makerere University, to propose that an HPTN site be established at the current MU/Mulago Hospital HIVNET Perinatal site for the purpose of conducting HIV-1 perinatal and other intervention trials. Uganda is a developing African country with HIV-1 seroprevalence rates varying between 17-20 percent among the 20,000 women who deliver at Mulago Hospital in Kampala, Uganda each year. The clinical, data management, and laboratory resources necessary to screen, enroll, and retain HIV-1 infected mother-infant pairs in HIV-1 perinatal intervention trials will be derived from the current facilities, personnel, and organizational structure of the existing MU-JHU research collaboration. The investigators are experienced in conducting HIV-1 perinatal intervention trials in Uganda involving more than 1500 mother-infant pairs, including the HIVNET 006 Phase I/II nevirapine trial, the HIVNET 012 Phase IIB nevirapine/zidovudine trial, the UNAIDS Phase III PETRA trial, and the Phase I/II HIVIG trial. In addition, a pilot behavioral study of perceptions, attitudes, and opinions of community members on strategies for the interruption of vertical transmission is underway, in collaboration with the MU Department of Sociology and Social Sciences. Two HIVNET protocols are currently planned for this site: (1) the HIVNET 012 Phase III trial of the nevirapine 012 regimen versus extended nevirapine dosing for prevention of HIV transmission during breastfeeding, and (2) the HIVNET 027 Phase I/II study of the safety and immunogenicity of the ALVAC HIV vaccine in infants born to HIV-infected Ugandan women. Future expansion at this site is possible in addition to the current perinatal, vaccine, and behavioral trials. Expansion is anticipated with participation in behavioral, microbicide, or sexually transmitted disease protocols, in collaboration with other working groups within the HIV Prevention Trials Network.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI048054-05
Application #
6770000
Study Section
Special Emphasis Panel (ZAI1-KWR-A (M1))
Program Officer
Ruiz, Monica S
Project Start
2000-07-01
Project End
2007-12-31
Budget Start
2004-07-01
Budget End
2007-12-31
Support Year
5
Fiscal Year
2004
Total Cost
$3,643,694
Indirect Cost

  Institution

Name
Johns Hopkins University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218

  Publications

Laeyendecker, Oliver; Brookmeyer, Ron; Cousins, Matthew M et al. (2013) HIV incidence determination in the United States: a multiassay approach. J Infect Dis 207:232-9
Kintu, Kenneth; Andrew, Philip; Musoke, Philippa et al. (2013) Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa. J Acquir Immune Defic Syndr 63:1-8
Curtis, Kelly A; Longosz, Andrew F; Kennedy, M Susan et al. (2013) Inter-laboratory assessment of a prototype multiplex kit for determination of recent HIV-1 infection. PLoS One 8:e77765
Owor, Maxensia; Mwatha, Anthony; Donnell, Deborah et al. (2013) Long-term follow-up of children in the HIVNET 012 perinatal HIV prevention trial: five-year growth and survival. J Acquir Immune Defic Syndr 64:464-71
Reller, Megan E; Chen, Wan Hsin; Dalton, Justin et al. (2013) Multiplex 5' nuclease quantitative real-time PCR for clinical diagnosis of malaria and species-level identification and epidemiologic evaluation of malaria-causing parasites, including Plasmodium knowlesi. J Clin Microbiol 51:2931-8
Laeyendecker, Oliver; Brookmeyer, Ron; Mullis, Caroline E et al. (2012) Specificity of four laboratory approaches for cross-sectional HIV incidence determination: analysis of samples from adults with known nonrecent HIV infection from five African countries. AIDS Res Hum Retroviruses 28:1177-83
Laeyendecker, Oliver; Brookmeyer, Ron; Oliver, Amy E et al. (2012) Factors associated with incorrect identification of recent HIV infection using the BED capture immunoassay. AIDS Res Hum Retroviruses 28:816-22
Keating, Sheila M; Hanson, Debra; Lebedeva, Mila et al. (2012) Lower-sensitivity and avidity modifications of the vitros anti-HIV 1+2 assay for detection of recent HIV infections and incidence estimation. J Clin Microbiol 50:3968-76
Kumwenda, Newton I; Khonje, Tiwonge; Mipando, Linda et al. (2012) Distribution of haematological and chemical pathology values among infants in Malawi and Uganda. Paediatr Int Child Health 32:213-27
Onyango-Makumbi, Carolyne; Omer, Saad B; Mubiru, Michael et al. (2011) Safety and efficacy of HIV hyperimmune globulin for prevention of mother-to-child HIV transmission in HIV-1-infected pregnant women and their infants in Kampala, Uganda (HIVIGLOB/NVP STUDY). J Acquir Immune Defic Syndr 58:399-407

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