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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00719602
First received: July 17, 2008
Last updated: October 8, 2014
Last verified: October 2014

July 17, 2008
October 8, 2014
April 2009
September 2013   (final data collection date for primary outcome measure)
Parasitemia in blood samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00719602 on ClinicalTrials.gov Archive Site
  • Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Severity of malarial disease [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • IL4-589C/T genotypes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • HIV Infections
  • Malaria
  • 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: 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
    Interventions:
    • Drug: Lamivudine
    • Drug: Lopinavir/Ritonavir
    • Drug: Nevirapine
    • Drug: Zidovudine
  • 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
    Interventions:
    • Drug: Lamivudine
    • Drug: Lopinavir/Ritonavir
    • Drug: Nevirapine
    • Drug: Zidovudine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
April 2015
September 2013   (final data collection date for primary outcome measure)

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.

Both
6 Months to 35 Months
No
Contact information is only displayed when the study is recruiting subjects
Malawi,   Uganda,   Zambia
 
NCT00719602
IMPAACT P1068s, U01AI068632
Yes
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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)
Study Chair: Charlotte Hobbs, MD New York University School of Medicine
Study Chair: William Borkowsky, MD New York University School of Medicine
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP