Relationship Between HIV and Malaria in Ugandan Children
NCT ID: NCT00356824
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2005-11-30
2010-05-31
Brief Summary
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Detailed Description
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This study will last 4 years. All participants will receive TMP/SMX as prophylaxis for malaria throughout this study. Children will be treated for all episodes of uncomplicated malaria with amodiaquine and artesunate; this treatment for malaria will be provided. Antiretroviral treatment for HIV, if deemed necessary by the study physician, will not be provided through this study. In the case of missed scheduled visits at the clinic, children and their parents or guardians will be visited at home by study staff, who will then bring the children and their parents and guardians to the clinic for their appointments.
Parents or guardians will be asked to bring children to the study clinic for all medical care. Unless instructed otherwise, the study clinic should be the only place where children in this study receive care and medications for the duration of the study. At each study visit for a new illness, children who have a temperature of 38 C (100.4 F) or greater, report having a fever in the 24 hours prior to the visit, or have suspected malaria will have their blood collected to check for malaria. If the blood is negative for malaria, the child will be treated with standard of care for the non-malaria illness in the Mulago Hospital complex.
If the blood is positive for malaria, the child will be classified as having either uncomplicated or complicated malaria. In cases of uncomplicated malaria, children will undergo medical history, a physical exam, and additional blood collection on the day of diagnosis (Day 0). Doses of amodiaquine and artesunate will be given once a day for 3 days in the study clinic by a study nurse, who will directly observe the child taking the medication. Study visits associated with uncomplicated malaria will occur on Days 1, 2, 3, 7, 14, 28, and any other day when the child feels ill; a physical exam and blood collection to check for malaria will occur at all visits. In cases of complicated malaria, children will be treated with quinine and will be referred to the Acute Care Unit of the Mulago Hospital complex.
Regardless of health during the course of the study, children will need to return to the clinic every 30 days to undergo a physical exam and blood collection to check for malaria. If malaria is found, children will undergo the 14-day standardized follow-up period as described above. At least every 3 months, additional blood collection will occur to determine HIV viral load, liver and kidney function, and immune parameters.
As of 07/01/08, all study participants with malaria will receive standard of care treatment through the Pediatric Infectious Disease Clinic. No treatment will be provided by the study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
HIV-infected children in Uganda
Amodiaquine
200 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Artesunate
50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Interventions
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Amodiaquine
200 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Artesunate
50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Resides within a 20 km (12.4 mi) radius of the study clinic in Kampala, Uganda
* Had a minimum of 1 regularly scheduled clinic visit in the 3 months prior to study entry
* Willing to return to the study clinic if fever or other illness occurs during this study
* Willing to avoid medications administered outside the Mulago Hospital Complex
* Parent or guardian willing to provide informed consent
Exclusion Criteria
* Weigh less than 5 kg (11 lbs)
* Participating in another Infectious Disease Clinic (IDC) cohort study
* Any current medical problem requiring in-patient evaluation or home care
* History of allergy or sensitivity to amodiaquine, artesunate, or quinine
* Life-threatening screening laboratory values in the absence of malaria. More information on this criterion can be found in the protocol.
1 Year
10 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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University of California, San Francisco
Principal Investigators
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Diane V. Havlir, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco and San Francisco General Hospital
Moses R. Kamya, MBChB, MMed, MPH
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Makerere University, Kampala, Uganda
Rukyalekere-Adeodadata Kekitiinwa
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Makerere University, Kampala, Uganda
Anne Gasasira
Role: PRINCIPAL_INVESTIGATOR
Makerere University Medical School, Makerere University, Kampala, Uganda
Israel Kalyesubula
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Makerere University, Kampala, Uganda
Grant Dorsey
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Edwin Charlebois
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Philip Rosenthal
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Huyen Cao
Role: PRINCIPAL_INVESTIGATOR
California Department of Human Services
Locations
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Pediatric Infectious Diseases Clinic, Mulago Hospital Complex
Kampala, , Uganda
Countries
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References
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Corbett EL, Steketee RW, ter Kuile FO, Latif AS, Kamali A, Hayes RJ. HIV-1/AIDS and the control of other infectious diseases in Africa. Lancet. 2002 Jun 22;359(9324):2177-87. doi: 10.1016/S0140-6736(02)09095-5.
Harms G, Feldmeier H. HIV infection and tropical parasitic diseases - deleterious interactions in both directions? Trop Med Int Health. 2002 Jun;7(6):479-88. doi: 10.1046/j.1365-3156.2002.00893.x.
Kalyesubula I, Musoke-Mudido P, Marum L, Bagenda D, Aceng E, Ndugwa C, Olness K. Effects of malaria infection in human immunodeficiency virus type 1-infected Ugandan children. Pediatr Infect Dis J. 1997 Sep;16(9):876-81. doi: 10.1097/00006454-199709000-00011.
Rowland-Jones SL, Lohman B. Interactions between malaria and HIV infection-an emerging public health problem? Microbes Infect. 2002 Oct;4(12):1265-70. doi: 10.1016/s1286-4579(02)01655-6.
Other Identifiers
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CHAMP
Identifier Type: -
Identifier Source: secondary_id