CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 176 enrolled
Drug / intervention
Lopinavir/Ritonavir (LPV/r) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00978068
NCT00978068Phase 3Completed

A Randomized Open Label Trial of HIV Protease Inhibitors for the Prevention of Malaria in HIV-Infected Children

University of California, San Francisco·interventional·Posted Sep 16, 2009·Updated Dec 28, 2018

In Brief

A Phase 3 clinical trial evaluating Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), and 2 other interventions for Malaria and HIV Infections. Completed, enrolled 176 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUganda

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.8 years ago

Interventions

Lopinavir/Ritonavir (LPV/r)drug

Nevirapine (NVP)drug

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

Efavirenz (EFV)drug

EFV for children ≥3 years of age

2 nucleoside reverse transcriptase inhibitor (NRTI)drug

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.