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Randomized Controlled Trial
. 2022 Feb 1;89(2):178-182.
doi: 10.1097/QAI.0000000000002839.

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)

Douglas Shaffer  1 , Johnstone Kumwenda  2 , Huichao Chen  3 , Victor Akelo  4 , Francis Angira  4 , Josphat Kosgei  5 , Ronald Tonui  6 , Francis Ssali  7 , Ashley McKhann  3 , Evelyn Hogg  8 , V Ann Stewart  9 , Sean C Murphy  10 , Robert Coombs  11   12 , Robert Schooley  13 ; A5297 Team
Affiliations
Randomized Controlled Trial

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)

Douglas Shaffer et al. J Acquir Immune Defic Syndr. .

Abstract

Background: HIV protease inhibitors anti-Plasmodium falciparum activity in adults remains uncertain.

Methods: Adults with HIV CD4+ counts >200 cells/mm3 starting antiretroviral therapy (ART) with P. falciparum subclinical parasitemia (Pf SCP) were randomized 1:1 to (step 1) protease inhibitor lopinavir/ritonavir (LPV/r)-based (arm A) or nonnucleoside reverse transcriptase inhibitor (nNRTI)-based ART (arm B) for 15 days. In step 2, participants received nNRTI-based ART and trimethoprim/sulfamethoxazole prophylaxis for 15 days. P. falciparum SCP clearance was measured by polymerase chain reaction. The Fisher exact test [95% exact confidence interval (CI)] was used to compare proportions of P. falciparum SCP clearance (<10 parasites/μL on 3 occasions within 24 hours) between LPV/r and nNRTI arms at day 15. The Kaplan-Meier method and log-rank test were used to compare time-to-clearance.

Results: Fifty-two adults from Kenya, Malawi, and Uganda with a median age = 31 (Q1, Q3: 24-39) years, 33% women, with baseline median CD4+ counts of 324 (259-404) cells/mm3, median HIV-1 RNA viremia of 5.18 log10 copies/mL (4.60-5.71), and median estimated P. falciparum density of 454 parasites/μL (83-2219) enrolled in the study. Forty-nine (94%) participants completed the study. At day 15, there was no statistically significant difference in the proportions of P. falciparum SCP clearance between the LPV/r (23.1% clearance; 6 of the 26) and nNRTI (26.9% clearance; 7 of the 26) arms [between-arm difference 3.9% (95% CI, -21.1% to 28.4%; P = 1.00)]. No significant difference in time-to-clearance was observed between the arms (P = 0.80).

Conclusions: In a small randomized study of adults starting ART with P. falciparum SCP, no statistically significant differences were seen between LPV/r- and nNRTI-based ART in P. falciparum SCP clearance after 15 days of treatment.

Trial registration: ClinicalTrials.gov NCT01632891.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.. Kaplan-Meier Plot of Time to Pf SCP Clearance (95% Confidence Bounds) between LPV/r and nNRTI based ART Treatment Arms (ACTG A5297)*
* The dotted line represents the median time to clearance.
See this image and copyright information in PMC

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