HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children

Summary

HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in Africa. Rather, improvements in malaria prevention are likely to come from strategies that employ multiple proven interventions targeting different populations. HIV-infected children represent one of the most vulnerable subpopulations in these countries. It is possible that the use of protease inhibitor (PI) - based antiretroviral therapy (ART) in HIV-infected children living in areas of high malaria transmission could prevent malaria in this vulnerable population. An effective remedy that offers the possibility to further reduce malaria risk, such as PIs, is highly desirable. This study will determine whether a PI based ART regimen will reduce malaria among children living in a malaria endemic area of Uganda and receiving insecticide-treated bed nets (ITN) and TS. This study will compare two different ART regimens. Children enrolled in the study will start or continue to receive either standard Ugandan first line treatment ART regimen (NNRTI+2 NRTIs) or an ART regimen containing the HIV protease inhibitor (lopinavir/ritonavir +2 NRTIs) and followed for a period of 24 months.

Conditions

• Malaria
• HIV Infections

Interventions

DRUG

Lopinavir/Ritonavir (LPV/r)

DRUG

Nevirapine (NVP)

NVP will be used for children \< 3 years of age

DRUG

Efavirenz (EFV)

EFV for children ≥3 years of age

DRUG

2 nucleoside reverse transcriptase inhibitor (NRTI)

The same NRTI choice strategy will be used for both arms. Lamivudine will be used with all children. The second NRTI will be zidovudine unless the participant has a hemoglobin \< 8 gm/dL, in which case it will be Abacavir. Stavudine will be used in the event that a participant is unable to take Abacavir for safety or other reasons.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Diane V Havlir, MD · University of California, San Francisco

• Moses R Kamya MBChB, MMed, MPH · Makerere University

• Grant Dorsey, MD, PhD · University of California, San Francisco

• Ted Ruel, MD · University of California, San Francisco

• Jane Achan, MBChB, MPed · Makerere University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• Uganda

Study Locations