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
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: April 2009
Estimated Study Completion Date: April 2015
Primary Completion Date: September 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

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
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
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
Investigators
Study Chair: Charlotte Hobbs, MD New York University School of Medicine
Study Chair: William Borkowsky, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
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: October 8, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Malaria
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Parasitic Diseases
Protozoan Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014