Relationship Between HIV and Malaria in Ugandan Children

NCT00356824 | Completed

• 2 other identifiers: U01AI062677-01CHAMP
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

HIV and malaria are two of the most important diseases to afflict children in sub-Saharan Africa. However, it is unknown what relationships exist between the two diseases. The purpose of this study is to determine the relationship between HIV and malaria infections in HIV infected Ugandan children.

Conditions

HIV Infections; Malaria

Keywords

Child

Study Arms (1)

1

HIV-infected children in Uganda

Drug: Amodiaquine; Drug: Artesunate

Interventions

Amodiaquine DRUG

200 mg oral tablet taken daily for 3 days under direct supervision at study clinic

Also known as: Camoquin

1

Artesunate DRUG

50 mg oral tablet taken daily for 3 days under direct supervision at study clinic

Also known as: Arsumax

1

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

HIV-infected children in Ugana at risk for malaria infection

You may qualify if:

• HIV infected
• 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

You may not qualify if:

• Intends to move more than 20 km (12.4 mi) from the study clinic during the follow-up period
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Pediatric Infectious Diseases Clinic, Mulago Hospital Complex

Kampala, Uganda

Location

Related Publications (4)

• 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.

  PMID: 12090997 BACKGROUND

• 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.

  PMID: 12031069 BACKGROUND

• 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.

  PMID: 9306483 BACKGROUND

• 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.

  PMID: 12467769 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

HIV Infections; Malaria

Interventions

Amodiaquine; Artesunate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Diane V. Havlir, MD

  University of California, San Francisco and San Francisco General Hospital

  PRINCIPAL INVESTIGATOR

• Moses R. Kamya, MBChB, MMed, MPH

  Department of Medicine, Makerere University, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

• Rukyalekere-Adeodadata Kekitiinwa

  Department of Pediatrics, Makerere University, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

• Anne Gasasira

  Makerere University Medical School, Makerere University, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

• Israel Kalyesubula

  Department of Pediatrics, Makerere University, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

• Grant Dorsey

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Edwin Charlebois

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Philip Rosenthal

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Huyen Cao

  California Department of Human Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 26, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2010
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

UG (1)