Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected

Summary

The purpose of this study was to see if antiretroviral therapy (ART) is safe and works at getting rid of malaria in blood and to see whether one type of ART is better than another. This study may offer information for further research in looking at whether ART plays a role in the prevention and treatment of malaria.

Timeline

Start

2014-01-10

Primary completion

2016-06-19

Completion

2016-06-19

Outcome

Missed primary endpoint

registry NUMBER LPV/R-based ART: Proportion Cleared: 0.23 Proportion of participants NCT01632891 ↗

registry NUMBER nNRTI-based ART: Proportion Cleared: 0.27 Proportion of participants NCT01632891 ↗

registry analysis (superiority test); LPV/R-based ART vs nNRTI-based ART; p = 1.00; Fisher Exact NCT01632891 ↗

Publications

• Shaffer D, Kumwenda J, Chen H, Akelo V, Angira F, Kosgei J, Tonui R, Ssali F, McKhann A, Hogg E, Stewart VA, Murphy SC, Coombs R, Schooley R; A5297 Team. Brief Report: No Differences Between Lopinavir/Ritonavir and Nonnucleoside Reverse Transcriptase Inhibitor-Based Antiretroviral Therapy on Clearance of Plasmodium falciparum Subclinical Parasitemia in Adults Living With HIV Starting Treatment (A5297). J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):178-182. doi: 10.1097/QAI.0000000000002839.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lopinavir	Other / unclassified	200 mg	Oral
Subject	Ritonavir	Other / unclassified	50 mg	Oral
Background	Efavirenz	Other / unclassified	600 mg	Oral
Background	Nevirapine	Small molecule	200 mg	Oral
Background	Sulfamethoxazole	Small molecule	800 mg	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Background	Trimethoprim	Small molecule	160 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral

Indications