Relationship Between HIV and Malaria in Ugandan Children
Condition: HIV Infections; Malaria
MeSH terms: Malaria
Study type: Observational

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.
    

Detailed description: 
      HIV and malaria are two of the most important infectious diseases in sub-Saharan Africa. By
      2000, over 25 million children and adults were living with HIV/AIDS, and 16 million people
      had died of the disease. Malaria is also of great importance in Africa, where over 90% of the
      500 million annual cases and 2.7 million annual deaths occur primarily in children under the
      age of 5. Any interaction between these two diseases is of tremendous public health
      importance; however, data in this area, especially information on the relevance of HIV and
      malaria coinfection, are limited. Little is known about HIV infection's effects on
      antimalarial therapy, the effects of anti-HIV treatment on malaria incidence and treatment
      outcomes, and the effect of malaria on HIV disease progression. This study will examine HIV
      infected children in Uganda and evaluate these relationships between HIV and malaria.

      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.
    

Intervention name(s): Amodiaquine; Artesunate
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg oral tablet taken daily for 3 days under direct supervision at study clinic; 50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Other intervention name(s): Camoquin; Arsumax
Intervention MeSH terms: Artesunate; Amodiaquine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-infected children in Ugana at risk for malaria infection
      
Biospecimen description: 
      Blood samples
    
Keywords: Child