Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT00719602
Brief Summary:
More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).
Detailed Description:
The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens.
This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.
This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study discontinuation. Participants must meet enrollment criteria for P1060 as well as additional criteria for this study. Study visits will occur as a part of P1060 study visits, all of which include a physical exam, blood collection, and assessments of HIV-related symptoms.
Participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.
Study:
NCT00719602
Study Brief:
Protocol Section:
NCT00719602