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

NCT00719602 | Completed Early Phase 1 DMC

• 2 other identifiers: IMPAACT P1068sU01AI068632
• Study Type: interventional
• Target: 105
• Locations: 3 countries
• Sites: 3

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).

Conditions

HIV Infections; Malaria

Keywords

Coinfection

Outcome Measures

Primary Outcomes (1)

• Parasitemia in blood samples

  Throughout study

Secondary Outcomes (4)

• Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy

  Throughout study

• Severity of malarial disease

  Throughout study

• Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines

  Throughout study

• IL4-589C/T genotypes

  Throughout study

Study Arms (2)

1

ACTIVE COMPARATOR

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; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Zidovudine

2

ACTIVE COMPARATOR

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; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Zidovudine

Interventions

Lamivudine DRUG

Taken orally twice daily

Also known as: 3TC

1; 2

Lopinavir/Ritonavir DRUG

Taken orally twice daily

Also known as: LPV/r

1; 2

Nevirapine DRUG

Taken orally twice daily

Also known as: NVP

1; 2

Zidovudine DRUG

Taken orally twice daily

Also known as: ZDV

1; 2

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• None.

Sponsors & Collaborators

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

Study Sites (3)

University of North Carolina Lilongwe (12001)

Lilongwe, Malawi

Location

Makerere University - JHU Research Collaboration (30293)

Kampala, Uganda

Location

George Clinic CRS (30273)

Lusaka, Zambia

Location

Related Publications (3)

• 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.

  PMID: 18575485 BACKGROUND

• 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.

  PMID: 18332766 BACKGROUND

• 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.

  PMID: 27936233 DERIVED

MeSH Terms

Conditions

HIV Infections; Malaria; Coinfection

Interventions

Lamivudine; Lopinavir; Nevirapine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyrimidinones; Pyridines; Thymidine

Study Officials

• Charlotte Hobbs, MD

  NYU Langone Health

  STUDY CHAIR

• William Borkowsky, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: August 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

ZA (1); MA (1); UG (1)