NCT00523510 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chantry CJ, Abrams BF, Donovan RM, Israel-Ballard KA, Sheppard HW
Breast milk pasteurization: appropriate assays to detect HIV inactivation. Infect Dis Obstet Gynecol. 2006;2006:95938.
Israel-Ballard K, Chantry C, Dewey K, Lönnerdal B, Sheppard H, Donovan R, Carlson J, Sage A, Abrams B
Viral, nutritional, and bacterial safety of flash-heated and pretoria-pasteurized breast milk to prevent mother-to-child transmission of HIV in resource-poor countries: a pilot study. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):175-81. Erratum in: J Acquir Immune Defic Syndr. 2006 Mar;41(3):396.
Israel-Ballard K, Coutsoudis A, Chantry CJ, Sturm AW, Karim F, Sibeko L, Abrams B
Bacterial safety of flash-heated and unheated expressed breastmilk during storage. J Trop Pediatr. 2006 Dec;52(6):399-405. Epub 2006 Sep 27.
Israel-Ballard K, Donovan R, Chantry C, Coutsoudis A, Sheppard H, Sibeko L, Abrams B
Flash-heat inactivation of HIV-1 in human milk: a potential method to reduce postnatal transmission in developing countries. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):318-23.
Israel-Ballard KA, Abrams BF, Coutsoudis A, Sibeko LN, Cheryk LA, Chantry CJ
Vitamin content of breast milk from HIV-1-infected mothers before and after flash-heat treatment. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):444-9. doi: 10.1097/QAI.0b013e31817beb8d. Erratum in: J Acquir Immune Defic Syndr. 2008 Oct 1;49(2):235.
Israel-Ballard KA, Maternowska MC, Abrams BF, Morrison P, Chitibura L, Chipato T, Chirenje ZM, Padian NS, Chantry CJ
Acceptability of heat treating breast milk to prevent mother-to-child transmission of human immunodeficiency virus in Zimbabwe: a qualitative study. J Hum Lact. 2006 Feb;22(1):48-60.

Feasibility and Pilot Efficacy of Flash-heated Breast Milk for Reduction of Maternal-to-Child Transmission of HIV in Tanzania

Details for clinical trial NCT00523510

Clinical trial NCT00523510 - References