Clinical Trials

MainTitle

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

This study has been completed
Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier
NCT00719602

First received: July 17, 2008
Last updated: September 16, 2016
Last Verified: September 2016
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
HIV Infections
Malaria

Drug : Lamivudine
Drug : Lopinavir/Ritonavir
Drug : Nevirapine
Drug : Zidovudine
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures

  • Parasitemia in blood samples [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy [ Time Frame: Throughout study ]
  • Severity of malarial disease [ Time Frame: Throughout study ]
  • Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines [ Time Frame: Throughout study ]
  • IL4-589C/T genotypes [ Time Frame: Throughout study ]

Enrollment: 105
Study Start Date: August 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 1
Previously received single-dose nevirapine (SD NVP); assigned to receive either an NNRTI- or PI-based regimen as a part of the study IMPAACT P1060
Drug: Lamivudine

Taken orally twice daily

Other Name: 3TC
Drug: Lopinavir/Ritonavir

Taken orally twice daily

Other Name: LPV/r
Drug: Nevirapine

Taken orally twice daily

Other Name: NVP
Drug: Zidovudine

Taken orally twice daily

Other Name: ZDV
Active Comparator: 2
Have not previously received SD NVP; assigned to receive either an NNRTI- or PI-based regimen as a part of the study IMPAACT P1060
Drug: Lamivudine

Taken orally twice daily

Other Name: 3TC
Drug: Lopinavir/Ritonavir

Taken orally twice daily

Other Name: LPV/r
Drug: Nevirapine

Taken orally twice daily

Other Name: NVP
Drug: Zidovudine

Taken orally twice daily

Other Name: ZDV

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

Eligibility

Ages Eligible for Study: 6 Months to 35 Months  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

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: NCT00719602

Locations

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

Sponsors and Collaborators

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

Investigators

Study Chair: Charlotte Hobbs, MD NYU Langone Health
Study Chair: William Borkowsky, MD NYU Langone Health
More Information

More Information


Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group  
ClinicalTrials.gov Identifier: NCT00719602   History of Changes  
Other Study ID Numbers: IMPAACT P1068s  
  U01AI068632  
Study First Received: July 17, 2008  
Last Updated: September 16, 2016  

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Coinfection

Additional relevant MeSH terms:
Infection
Malaria
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine

ClinicalTrials.gov processed this data on September 17, 2019
This information is provided by ClinicalTrials.gov.