Relationship Between HIV and Malaria in Ugandan Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00356824
First received: July 25, 2006
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
HIV Infections
Malaria
Drug: Amodiaquine
Drug: Artesunate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Study of Interactions Between HIV and Malaria in Ugandan Children: A UCSF/Makerere University "Children With HIV and Malaria Project"

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 300
Study Start Date: November 2005
Study Completion Date: May 2010
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
HIV-infected children in Uganda
Drug: Amodiaquine
200 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Other Name: Camoquin
Drug: Artesunate
50 mg oral tablet taken daily for 3 days under direct supervision at study clinic
Other Name: Arsumax

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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-infected children in Ugana at risk for malaria infection

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356824

Locations
Uganda
Pediatric Infectious Diseases Clinic, Mulago Hospital Complex
Kampala, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Diane V. Havlir, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00356824     History of Changes
Other Study ID Numbers: U01 AI062677-01, CHAMP
Study First Received: July 25, 2006
Last Updated: July 30, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Child

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Malaria
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on August 27, 2014