nevirapine and Malnutrition studies

Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.
nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.

Malnutrition: An imbalanced nutritional status resulting from insufficient intake of nutrients to meet normal physiological requirement.

Research Excerpts

Excerpt	Relevance	Reference
"To determine the relationship between nutritional status and nevirapine exposure by comparing the pharmacokinetics of nevirapine in HIV-infected children of different ages with and without malnutrition receiving divided tablets of Triomune 30 (stavudine + lamivudine + nevirapine) in accordance with Malawi National Guidelines."	7.75	Pharmacokinetics of nevirapine in HIV-infected children with and without malnutrition receiving divided adult fixed-dose combination tablets. ( Back, D; Else, L; Fraser, W; Khoo, S; Molyneux, E; Moons, P; Poerksen, G; Pollock, L; Walker, S, 2009)
" Compared to RRC, Ugandan children exhibited reduced bioavailability of EFV and LPV; 11% (P=0."	5.42	The effect of malnutrition on the pharmacokinetics and virologic outcomes of lopinavir, efavirenz and nevirapine in food insecure HIV-infected children in Tororo, Uganda. ( Achan, J; Aweeka, F; Bartelink, IH; Capparelli, E; Charlebois, E; Dorsey, G; Gingrich, D; Havlir, D; Jullien, V; Kamya, M; Plenty, A; Ruel, T; Savic, RM; Scherpbier, HJ; Young, SL, 2015)
"To determine the relationship between nutritional status and nevirapine exposure by comparing the pharmacokinetics of nevirapine in HIV-infected children of different ages with and without malnutrition receiving divided tablets of Triomune 30 (stavudine + lamivudine + nevirapine) in accordance with Malawi National Guidelines."	3.75	Pharmacokinetics of nevirapine in HIV-infected children with and without malnutrition receiving divided adult fixed-dose combination tablets. ( Back, D; Else, L; Fraser, W; Khoo, S; Molyneux, E; Moons, P; Poerksen, G; Pollock, L; Walker, S, 2009)
" However, pharmacokinetic knowledge is lacking for specific populations, especially patients with neglected tropical diseases and severe malnutrition."	2.72	Influence of Malnutrition on the Pharmacokinetics of Drugs Used in the Treatment of Poverty-Related Diseases: A Systematic Review. ( Beijnen, JH; Dorlo, TPC; Huitema, ADR; Verrest, L; Wilthagen, EA, 2021)
" Compared to RRC, Ugandan children exhibited reduced bioavailability of EFV and LPV; 11% (P=0."	1.42	The effect of malnutrition on the pharmacokinetics and virologic outcomes of lopinavir, efavirenz and nevirapine in food insecure HIV-infected children in Tororo, Uganda. ( Achan, J; Aweeka, F; Bartelink, IH; Capparelli, E; Charlebois, E; Dorsey, G; Gingrich, D; Havlir, D; Jullien, V; Kamya, M; Plenty, A; Ruel, T; Savic, RM; Scherpbier, HJ; Young, SL, 2015)

Research

Studies (4)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

28-day Risk of Recurrent Parasitemia

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (50.00)	29.6817
2010's	1 (25.00)	24.3611
2020's	1 (25.00)	2.80

Authors	Studies
Verrest, L	1
Wilthagen, EA	1
Beijnen, JH	1
Huitema, ADR	1
Dorlo, TPC	1
Bartelink, IH	1
Savic, RM	1
Dorsey, G	1
Ruel, T	1
Gingrich, D	1
Scherpbier, HJ	1
Capparelli, E	1
Jullien, V	1
Young, SL	1
Achan, J	1
Plenty, A	1
Charlebois, E	1
Kamya, M	1
Havlir, D	1
Aweeka, F	1
van der Horst, C	1
Chasela, C	1
Ahmed, Y	1
Hoffman, I	1
Hosseinipour, M	1
Knight, R	1
Fiscus, S	1
Hudgens, M	1
Kazembe, P	1
Bentley, M	1
Adair, L	1
Piwoz, E	1
Martinson, F	1
Duerr, A	1
Kourtis, A	1
Loeliger, AE	1
Tohill, B	1
Ellington, S	1
Jamieson, D	1
Pollock, L	1
Else, L	1
Poerksen, G	1
Molyneux, E	1
Moons, P	1
Walker, S	1
Fraser, W	1
Back, D	1
Khoo, S	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized Open Label Trial of HIV Protease Inhibitors for the Prevention of Malaria in HIV-Infected Children[NCT00978068]	Phase 3	176 participants (Actual)	Interventional	2009-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent parasitemia at 28 days were compared between the two groups. (NCT00978068)
Timeframe: 28 days after antimalarial therapy

63-day Risk of Recurrent Malaria

Intervention	Cummulative Risk Percentage (Number)
LPV/r + 2 NRTIs	14.0
NVP or EFV + 2 NRTIs	40.8

To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent malaria at 63 days were compared between the two groups. (NCT00978068)
Timeframe: 28 days after antimalarial therapy

Estimates of the 6-month Risk of a First Episode of Malaria

Intervention	Cumulative Risk Percentage (Number)
LPV/r + 2 NRTIs	28.1
NVP or EFV + 2 NRTIs	54.2

To assess the effect of ART independently of potential interactions with antimalarial therapy after treatment for malaria, we compared the two groups with respect to the time to the first episode of malaria. Cumulative risk was estimated using the Kaplan-Meier product-limit formula. (NCT00978068)
Timeframe: Enrollment to 6 months follow up

Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk.

Intervention	Cumulative Risk Percentage (Number)
LPV/r + 2 NRTIs	40.7
NVP or EFV + 2 NRTIs	52.5

(NCT00978068)
Timeframe: Time from randomization to at least 24 months of follow up or until end of the study

Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk.

Intervention	Episodes/ Person-Yr at Risk (Number)
Group 1	0.024
Group 2	0.026