Co-administration of a daily dose of artesunate (Arsumax) 4mg/kg and amodiaquine (Flavoquine) 10mg/kg for 3 days, under direct observation. Children <12months <10kg: artesunate (Arsumax) 50mg - 0.5tab/day + amodiaquine (Flavoquine) 153mg - 0.5tab/day; Children 12-59months 10-20kg: artesunate (Arsumax) 50mg - 1 tab/day + amodiaquine (Flavoquine) 153mg 1 tab/day.

Artemether-lumefantrine (Coartem®) - artemether 1.3mg/kg + lumefantrine 4mg/kg administered twice daily, both doses under direct observation either in the clinic or in the patient's home. Children <60 months, 5-14kg: 1 tab/dose; Children <60 months >14kg: 2 tabs/dose.

Plasmodium Falciparum Malaria

Three day treatment with Artemether-lumefantrine, 2 doses a day under direct observation

Artemether-lumefantrine

Three day treatment with Artesunate + Amodiaquine, co-administered, a dose a day under direct observation

Artesunate + Amodiaquine

Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005

A Multicentre Randomised Comparative Clinical Trial of the Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine (Coartem®) for the Treatment of Uncomplicated Childhood Plasmodium Falciparum Malaria in Zanzibar

Comparing PCR adjusted parasitological cure rate (PCR-APCR) between the two treatment options up to day 42. Parasitological cure will be adjusted using PCR genotyping of msp2 marker. Recrudescence is defined as the presence of at least one matching allelic band, and reinfection as the absence of any matching allelic band on day 0 and day of recurring parasitaemia. Patients with recurrent parasitaemia having missing filter paper sample or negative PCR results will be considered uncertain with regards to PCR adjusted outcome.

Comparing proportion of response outcomes according to standard WHO classification i.e., cure rates on days 14, day 28 and 42. Defined as the absence of both re-parasitaemia and clinical symptoms suggestive of severe malaria during follow-up to the respective days.

Proportion of patients reporting any adverse event (AE) in the two study arms. The intensity of an adverse event was determined according to the following definitions: mild, moderate, severe, unknown. AEs were be categorized according to if there is a likely causal relationship between the event and the medical products: probably, possibly, unlikely.

Fever clearance was determined by a medical doctor/officer who measured the patient's axillary temperature using an electronic thermometer and took a detailed clinical history as well as performed a clinical examination. All details were recorded in the CRF.

Clearance of parasites and gametocyte carriage were determined by Giemsa stained thick blood films were examined using electrical or sunlight microscope at the study site by an experienced microscopist. The number of parasites were calculated as the number of parasites seen against 200 leucocytes in the thick blood film and recorded in the CRF for the correct occasion. The slides were stored for quality controls, 10% of all slides were double-checked centrally.

Proportions of single nucleotide polymorphisms at pfmdr1 Y86N and pfcrt K76T determined by established AluI restriction-based PCR-RFLP.

Professor Anders Björkman

Professor

Zanzibar Malaria Control Programme

A multicentre randomised comparative clinical trial of the efficacy of ASAQ versus AL for the treatment of uncomplicated childhood Plasmodium falciparum malaria.

No blinding was done due to the different drug formulations and regimens.

Neonatal Hyperbilirubinemia

Shoklo Malaria Research Unit

Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

A Prospective Cohort Study on the Etiology of Neonatal Hyperbilirubinemia in a Migrant and Refugee Population on the Thai-Myanmar Border

Establish the causes contributing to the development of neonatal hyperbilirubinemia in this population, including a detailed description of the clinical course of neonates with neonatal hyperbilirubinemia.

University of Oxford

Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.

Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.

LPV/R-based ART

nNRTI-based ART

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

CD4 cell count

Log10(HIV-1 RNA)

Log10(parasite density)

Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.
If a participant had missing data on day 15, they were considered as not having clearance.

Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance

Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite.

Time to First Pf SCP Clearance

Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017.

Log10(Pf Parasite Density)

Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.
Change is evaluated in four groups:
Randomized to nNRTI-based ART with continued Pf SCP at day 15
Randomized to nNRTI-based ART with clearance of Pf SCP at day 15
Randomized to LPV/r-based ART with continued Pf SCP at day 15
Randomized to LPV/r-based ART with clearance of Pf SCP at day 15

Randomized to nNRTI based ART with continued Pf SCP at day 15

nNRTI-based ART, Not Cleared

Randomized to nNRTI based ART with clearance of Pf SCP at day 15

nNRTI-based ART, Cleared

Randomized to LPV/r based ART with continued Pf SCP at day 15

LPV/R-based ART, Not Cleared

Randomized to LPV/r based ART with clearance of Pf SCP at day 15

LPV/R-based ART, Cleared

Change in log10(Pf Parasite Density) From Entry to Day 30

Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication.

Number of Participants With Uncomplicated Clinical Malaria

Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous.

Number of Participants With Detectable Pf Gametocyte Density

Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:
Randomized to nNRTI-based ART with continued Pf SCP at day 15
Randomized to LPV/r-based ART with continued Pf SCP at day 15
Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30.

Change in log10(Pf Gametocyte Density) From Entry to Day 30

Overall Study

ACTG Clinicaltrials.gov Coordinator

HIV-1 Infection

Pf Subclinical Parasitemia

Participants received two 200 mg/50 mg tablets of lopinavir/ritonavir orally twice daily.

Lopinavir/ritonavir

Participants received one 200 mg/300 mg tablet of Emtricitabine/tenofovir disoproxil fumarate orally once daily.

Emtricitabine/tenofovir disoproxil fumarate

Participants received one 600 mg tablet of efavirenz orally once daily.

Efavirenz

If unable to take efavirenz, participants received on 200 mg tablet of nevirapine orally once daily.

Nevirapine

Participants received one 160 mg/800 mg tablet of trimethoprim/sulfamethoxazole orally once daily.

Trimethoprim/sulfamethoxazole

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004

Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501)

Kisumu Crs (31460)

College of Med. JHU CRS (30301)

Joint Clinical Research Centre (JCRC) (12401)

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

An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <500 Cells/mm^3

AIDS Clinical Trials Group

National Institute of Allergy and Infectious Diseases (NIAID)

Malaria

Prevention and Control

Acquired Immunity

PfSPZ

National Institutes of Health Clinical Center, 9000 Rockville Pike

Experimental PfSPZ Vaccine in Adults Without Malaria

VRC 312: A Phase 1, Open-Label, Dose-Escalation Clinical Trial With Experimental Challenge to Evaluate Intravenous Administration of the PfSPZ Vaccine in Malaria-Naive Adults

malaria/albumiini

Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005

Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

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

Experimental PfSPZ Vaccine in Adults Without Malaria

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