Impact of TMP-SMX Prophylaxis on Malaria Infection and Immunity in Children in Uganda

NCT02094508 | Completed

• 2 other identifiers: 99991407314-I-N073
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Infants will be screened with a medical history and physical exam. A small amount of blood will be taken. The mothers medical records will be reviewed. Mothers will be asked about when they breastfeed.
• Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers will get a mosquito net with insecticide on it as per standard of care.
• Participants will come to the clinic once a month, every month, until the study ends in 2 3 years. Each visit will repeat the screening visit.
• Participants will also visit the clinic every month for a medical history, physical exam, and different blood tests.
• Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the clinic and will either be taken off the drug or will continue taking the drug for 6 more months.
• If a child becomes sick, it is important that the mother bring him or her to the RHSP clinic in Rakai.

Conditions

Malaria

Keywords

Parasitemia; HIV-Exposed; HIV-Unexposed; Liver Stage; Randomized

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant must be born during the period beginning May 1, 2014 and ending November 30, 2014.
• Mothers of HUE subjects must be giving their child TMP-SMX prophylaxis at screening (this does not apply to HUU subjects).
• Mothers must be breastfeeding their child at screening.
• Parent/legal guardian must be able and willing to provide signed informed consent on behalf of the child subject, agree to bring the child to the study site for visits, and seek medical care for intercurrent illness for the child subject at the study site.
• Parent/legal guardian of HUE subjects must agree to be compliant with administering the daily prophylactic doses of TMP-SMX according to the standard guidelines.
• Mothers must consent to a review of their medical records and a monthly assessment of breastfeeding status.
• Mother/guardian must live within the Rakai District.

You may not qualify if:

• Child has a diagnosis of HIV-infection or clinical or laboratory evidence of other chronic infection or disease (including renal or hepatic insufficiency).
• Clinical determination of conditions that would exclude the child
• based on record review, history, and examination.
• Participation in a malaria vaccine study or have a history of
• involvement in such a study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Rakai Health Sciences Program Uganda Virus Research Institute

Kalisizo, Uganda

Location

Related Publications (4)

• 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.

  PMID: 22536311 BACKGROUND

• 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.

  PMID: 21700241 BACKGROUND

• 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.

  PMID: 19032102 BACKGROUND

• 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.

  PMID: 29692311 DERIVED

MeSH Terms

Conditions

Malaria; Parasitemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: March 7, 2014
• Primary Completion: December 28, 2015
• Study Completion: December 14, 2016
• Last Updated: April 5, 2018

Record last verified: 2016-12-14

Locations

UG (1)