Participants will be on routine HAART only. No Artemisia Annua, Moringa oleifera will be given.

Participants will be given HAART and Artemisia annua leaf powder 4 g per day. They will only receive Artemisia Annua, Moringa oleifera will not be given.

Participants will be given HAART with Artemisia annua leaf powder of 4 grams per day and Moringa oleifera leaf powder of 10 grams per day. Both Artemisia Annua, Moringa oleifera will be given.

HIV Infections

Artemisia Annua, Moringa oleifera

Mbarara Regional Referral Hospital

Evaluation of Artemisia Annua and Moringa

EVALUATION OF THE EFFECT OF ARTEMISIA ANNUA AND MORINGA OLEIFERA ON IMMUNOLOGICAL RESPONSE IN HAART HIV PATIENTS at MRRH

The primary outcome will be change in CD4 counts (absolute and relative) at 6 and 12 months in study participants following enrollment in the study.

Viral load at baseline, 6 and 12 months from time of initiating herbal treatment with the above mentioned herbs.

Complete Blood Count at baseline, 6 and 12 months

Immunoglobins (E, A, G) associated with HIV infections in HAART patients at baseline, 6 and 12 months

Antiretroviral plasma drug level in HAART patients at baseline and after one and two weeks

Liver function biomarkers at baseline, six and twelve months

Incidence of side effects or adverse drug reactions in the study participants over the study period

Renal function biomarkers at baseline, six and twelve months

Participant lab results will be availed to the attending physician

Mbarara University of Science and Technology

ANAMED

Participants will be stratified according to baseline CD4 levels: 350 - 250, 249 - 150, below 149. Computer generated numbers will be used to assign selected participants into study groups using simple randomization method to either control group with HAART only, or HAART with Artemisia annua group or HAART with Artemisia annua and Moringa oleifera group of 1:1:1.

Two research assistants will be recruited and trained as observers and data collectors to increase accuracy and consistency in documenting the needed data. They will be assisted by the HIV clinic staff and these research assistants will be blinded to the hypotheses of this study to minimize observer bias and facilitate participant randomization. Senior clinician at the HIV clinic will supervise the trial and administration of treatments for HAART patients attending at the MRRH clinic.
To endure blinding, a study nurse will randomize and interview the participants and or draw blood whenever necessary. Study phlebotomist will draw blood and deliver it to the respective laboratory with codes masking the arm in which that patient is randomized. Independent laboratory technicians will run the tests at Epicenter and MUST research Labs.

Arthemeter-lumefantrine (ART-LUM) is an antimalaria drug manufactured as fixed combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. ART-LUM was administrated according to body weight as six consecutive doses: The first dose at diagnosis and the second dose eight hours later, 0- 24-48 hours

Artesunate mefloquine (ASMQ) is an antimalaria drug administered as a combination of artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days or three times, at an interval of 24 hours (0 h - 24 h - 48 h).

Dihydroartemisinin piperaquine (DHA-PQ ) is an antimalaria drug administered as a combination of dihydroartemisinin, 2.5 mg per kg, with piperaquine phosphate, 20mg per kg daily for 3 days or three times, at an interval of 24 hours

Oral paracetamol is administered at of 50mg/kg body weight per day in three divided doses for fever exceeding 37.5oC.

amoxicillin is an antibiotic administered at 50mg per kg body weight per day for seven days in the event of concomitant bacterial infection, absent on day 0 but present during the follow up.

Quinine is an antimalarial recommended by the WHO and NMCP to be used as second line treatment for malaria. In this study, for cases of treatment failure with the artemisinin based combination therapies, quinine sulphate is administered as a second line or rescue drug at a dose of 25mg base per kg body weight per day in three divided doses for five days. The participant is then classified as ETF or LTF and excluded from the study.

Drug Resistant Malaria Due to Plasmodium Falciparum

Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.

Arthemeter-lumefantrine

Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs

Artesunate mefloquine

Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs

Dihydroartemisinin piperaquine

Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation

Paracetamol

Amoxicillin is an antibiotic with no reported activity on plasmodium

Amoxicillin

quinine sulphate is an antimalaria drug administered as a second line or rescue drug

Quinine

CDC Hospital

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

The primary endpoint was the 28-day and 42-day cure rates and was defined as proportion of patients with adequate clinical and parasitological response (ACPR) after 28 and 42 days of follow-up. Absence of parasitemia until day 28 and day 42 irrespective of axillary temperature was categorized as an adequate clinical and parasitologic response (ACPR). Secondary endpoints were early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), adverse events (clinical and laboratory abnormalities), anaemia (Hematocrit < 30%), clearance rate of fever and parasitaemia, and gametocyte

The ability of the drug to restore hemoglobin level back to normal

The ability of the drug to completely eliminate plasmodium in the blood stream including participant without symptoms of fever

blood sample from patients with parasitaemia at any day of follow-up are analysed by PCR to evaluated the genetic profile of the MSP1 and MSP2

University of Bamenda

Ministry of Science and Technology of the People´s Republic of China

National Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention

Malaria

once every month during september, October and November

SP, amodiaquine, piperaquine, dihdroartemisinin

SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Du-Cotecxin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days

intermittent preventive treatment

Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days

Du-Cotecxin

Medical Research Council Laboratories,

Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia

dihydroartemisinin/mučnina

Evaluation of Artemisia Annua and Moringa

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

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