Clinical trial NCT00719602: Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: HIV Infections
Malaria
Keywords: Coinfection
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-07-21
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Enrolling in study IMPAACT P1060
* Parent/legal guardian agrees to seek medical care for intercurrent illness at the study site, whenever possible, and agree to not use at-home remedies for febrile illness in the child

Exclusion Criteria:

None.

Primary outcomes:
measure: Parasitemia in blood samples
timeFrame: Throughout study
Secondary outcomes:
measure: Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy
timeFrame: Throughout study
measure: Severity of malarial disease
timeFrame: Throughout study
measure: Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines
timeFrame: Throughout study
measure: IL4-589C/T genotypes
timeFrame: Throughout study
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: University of North Carolina Lilongwe (12001)
city: Kampala
country: Uganda
facility: Makerere University - JHU Research Collaboration (30293)
city: Lusaka
country: Zambia
facility: George Clinic CRS (30273)
Study officials:
affiliation: NYU Langone Health
name: Charlotte Hobbs, MD
role: STUDY_CHAIR
affiliation: NYU Langone Health
name: William Borkowsky, MD
role: STUDY_CHAIR
References:
citation: Adetifa IM, Akinsulie AO, Temiye EO, Iroha EO, Ezeaka VC, Mafe AG, Grange AO. Effect of antiretroviral therapy on asymptomatic malaria parasitaemia in HIV-1 infected children. Niger Postgrad Med J. 2008 Jun;15(2):120-5.
citation: Brahmbhatt H, Sullivan D, Kigozi G, Askin F, Wabwire-Mangenm F, Serwadda D, Sewankambo N, Wawer M, Gray R. Association of HIV and malaria with mother-to-child transmission, birth outcomes, and child mortality. J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):472-6. doi: 10.1097/QAI.0b013e318162afe0.
citation: Hobbs CV, Gabriel EE, Kamthunzi P, Tegha G, Tauzie J, Petzold E, Barlow-Mosha L, Chi BH, Li Y, Ilmet T, Kirmse B, Neal J, Parikh S, Deygoo N, Jean Philippe P, Mofenson L, Prescott W, Chen J, Musoke P, Palumbo P, Duffy PE, Borkowsky W; P1068s Study Team. Malaria in HIV-Infected Children Receiving HIV Protease-Inhibitor- Compared with Non-Nucleoside Reverse Transcriptase Inhibitor-Based Antiretroviral Therapy, IMPAACT P1068s, Substudy to P1060. PLoS One. 2016 Dec 9;11(12):e0165140. doi: 10.1371/journal.pone.0165140. eCollection 2016.