NCT00719602

Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART

P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Malaria

Interventions

Type	Name	Description
DRUG	Lamivudine	Taken orally twice daily
DRUG	Lopinavir/Ritonavir	Taken orally twice daily
DRUG	Nevirapine	Taken orally twice daily
DRUG	Zidovudine	Taken orally twice daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2008-07-21
• Last updated: 2016-09-19

Locations

3 sites across 3 countries: Malawi, Uganda, Zambia