NCT02094508|Completed
Impact of TMP-SMX Prophylaxis on Malaria Infection and Immunity in Children in Uganda
Impact of Trimethoprim-sulfamethoxazole Prophylaxis on Malaria Infection and Immunity in Children in Uganda
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Impact of Trimethoprim-sulfamethoxazole Prophylaxis on Malaria Infection and Immunity in Children in Uganda
Sponsor study identifier
Secondary identifiers
observational
173
1 country
1
Study Start
March 7, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 28, 2015
Actual (reported)Study Completion
December 14, 2016
Actual (reported)Background: \- Malaria is a disease that affects many children and adults in Uganda and Africa. If it is not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is a drug that is given to children born to HIV-positive mothers to help prevent infection. Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of infection in the body, which may positively impact the way the body can fight malaria infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps children fight malaria better in this way. Objective: \- To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants. Eligibility: \- Infants 0-6 weeks of age who are HIV negative. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 20, 2014
Actual (reported)March 21, 2014
Actual (reported)December 28, 2015
Actual (reported)December 14, 2016
Actual (reported)Malaria incidence rate (number of new malaria parasitemia episodes per time at risk) in HUE children on TMP-SMX prophylaxis compared to HUU children (not on TMP-SMX prophylaxis) between enrollment and study end. A malaria parasitemia episode is ...
At end of the study
Rakai Health Sciences Program Uganda Virus Research Institute
Kalisizo, Uganda
Mutanga JN, Raymond J, Towle MS, Mutembo S, Fubisha RC, Lule F, Muhe L. Institutionalizing provider-initiated HIV testing and counselling for children: an observational case study from Zambia. PLoS One. 2012;7(4):e29656. doi: 10.1371/journal.pone.0029656. Epub 2012 Apr 20.
Flateau C, Le Loup G, Pialoux G. Consequences of HIV infection on malaria and therapeutic implications: a systematic review. Lancet Infect Dis. 2011 Jul;11(7):541-56. doi: 10.1016/S1473-3099(11)70031-7.
Steven J Reynolds, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
173 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2014
First Posted
March 21, 2014
Study Start
March 7, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates
Contact the study team to confirm eligibility.
Hobbs CV, Voza T, Coppi A, Kirmse B, Marsh K, Borkowsky W, Sinnis P. HIV protease inhibitors inhibit the development of preerythrocytic-stage plasmodium parasites. J Infect Dis. 2009 Jan 1;199(1):134-41. doi: 10.1086/594369.
Kasule J, Gabriel EE, Anok A, Neal J, Eastman RT, Penzak S, Newell K, Serwadda D, Duffy PE, Reynolds SJ, Hobbs CV. Sulfamethoxazole Levels in HIV-Exposed Uninfected Ugandan Children. Am J Trop Med Hyg. 2018 Jun;98(6):1718-1721. doi: 10.4269/ajtmh.17-0933. Epub 2018 Apr 19.
Primary Completion
December 28, 2015
Actual (reported)Study Completion
December 14, 2016
Actual (reported)Last Updated
April 5, 2018
Record last verified: 2016-12-14
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Source: ClinicalTrials.gov.
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