Phase 3
Completed N=176
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
Source: ClinicalTrials.gov NCT00978068 ↗Enrolled (actual)
176
Serious AEs
11.8%
Results posted
Dec 2018
Primary outcomePrimary: Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. — 1.32; 2.25 Episodes/ Person-Yr at Risk — p=0.04
◆ Published Evidence
Highly cited
111citations · ~8 / year
Antiretroviral agents and prevention of malaria in HIV-infected 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.
Linked Publications (5)
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Antiretroviral agents and prevention of malaria in HIV-infected Ugandan children.
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In vitro activity of antiretroviral drugs against Plasmodium falciparum.
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Artemisinin-based combination therapies are efficacious and safe for treatment of uncomplicated malaria in HIV-infected Ugandan children.
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Virologic and immunologic outcomes of HIV-infected Ugandan children randomized to lopinavir/ritonavir or nonnucleoside reverse transcriptase inhibitor therapy.
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Prevalence of asymptomatic parasitemia and gametocytemia among HIV-infected Ugandan children randomized to receive different antiretroviral therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. |
1.32; 2.25 | 0.04 sig |
| SECONDARY Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy |
71.0; 79.3 | 0.13 |
| SECONDARY Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk. |
0.024; 0.026 | 0.87 |
| SECONDARY Estimates of the 6-month Risk of a First Episode of Malaria |
40.7; 52.5 | 0.14 |
| SECONDARY 28-day Risk of Recurrent Parasitemia |
14.0; 40.8 | 0.004 sig |
| SECONDARY 63-day Risk of Recurrent Malaria |
28.1; 54.2 | 0.004 sig |
Eligibility Criteria
Inclusion criteria
- Age 2 months to 18 months: Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test ii. Children 113U/L (>2.5xULN)
- ALT: >113U/L (>2.5xULN)
- Life-threatening (Grade 4) screening laboratory value found within 4 weeks prior to enrollment for the following:
- Absolute neutrophil count: 3.5xULN
- Platelets: <25,000/mm3
Data sourced from ClinicalTrials.gov (NCT00978068) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.