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)
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:89 |
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| Enthalten in: |
Journal of acquired immune deficiency syndromes (1999) - 89(2022), 2 vom: 01. Feb., Seite 178-182 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shaffer, Douglas [VerfasserIn] |
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| Links: |
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| Themen: |
2494G1JF75 |
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| Anmerkungen: |
Date Completed 08.03.2022 Date Revised 27.09.2023 published: Print ClinicalTrials.gov: NCT01632891 Citation Status MEDLINE |
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| doi: |
10.1097/QAI.0000000000002839 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM332340309 |
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| 100 | 1 | |a Shaffer, Douglas |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Brief Report |b 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) |
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| 500 | |a Date Completed 08.03.2022 | ||
| 500 | |a Date Revised 27.09.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01632891 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: HIV protease inhibitors anti-Plasmodium falciparum activity in adults remains uncertain | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a HIV Protease Inhibitors |2 NLM | |
| 650 | 7 | |a Reverse Transcriptase Inhibitors |2 NLM | |
| 650 | 7 | |a Lopinavir |2 NLM | |
| 650 | 7 | |a 2494G1JF75 |2 NLM | |
| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 700 | 1 | |a Kumwenda, Johnstone |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Huichao |e verfasserin |4 aut | |
| 700 | 1 | |a Akelo, Victor |e verfasserin |4 aut | |
| 700 | 1 | |a Angira, Francis |e verfasserin |4 aut | |
| 700 | 1 | |a Kosgei, Josphat |e verfasserin |4 aut | |
| 700 | 1 | |a Tonui, Ronald |e verfasserin |4 aut | |
| 700 | 1 | |a Ssali, Francis |e verfasserin |4 aut | |
| 700 | 1 | |a McKhann, Ashley |e verfasserin |4 aut | |
| 700 | 1 | |a Hogg, Evelyn |e verfasserin |4 aut | |
| 700 | 1 | |a Stewart, V Ann |e verfasserin |4 aut | |
| 700 | 1 | |a Murphy, Sean C |e verfasserin |4 aut | |
| 700 | 1 | |a Coombs, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Schooley, Robert |e verfasserin |4 aut | |
| 700 | 0 | |a A5297 Team |e verfasserin |4 aut | |
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