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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719602
• Other study ID #: IMPAACT P1068s
• Secondary ID: U01AI068632
• Status: Completed
• Phase: Phase 0
• First received: July 17, 2008
• Last updated: September 16, 2016
• Start date: August 2009
• Est. completion date: August 2013

Study information

• Verified date: September 2016
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection
• Malaria

Intervention

Drug:
• Lamivudine
Taken orally twice daily
• Lopinavir/Ritonavir
Taken orally twice daily
• Nevirapine
Taken orally twice daily
• Zidovudine
Taken orally twice daily

Locations

Country	Name	City	State
Malawi	University of North Carolina Lilongwe (12001)	Lilongwe
Uganda	Makerere University - JHU Research Collaboration (30293)	Kampala
Zambia	George Clinic CRS (30273)	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

Malawi,  Uganda,  Zambia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitemia in blood samples		Throughout study	No
Secondary	Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy		Throughout study	No
Secondary	Severity of malarial disease		Throughout study	Yes
Secondary	Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines		Throughout study	No
Secondary	IL4-589C/T genotypes		Throughout study	No

External Links

•   Click here for more information about zidovudine