anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydroxychloroquine
Trial phase: Phase 2 | Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Subjects in this arm will receive the study drug

Hydroxychloroquine: Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
Eligibility criteria:
Inclusion Criteria:

Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
Male or Female age 19 to 89 years
Able to take oral medications
Patients not requiring hospitalization
Provision of informed consent

Exclusion Criteria:

Known history of EKG QTc prolongation abnormality
Contraindication or allergy to hydroxychloroquine
Retinal eye disease
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Known chronic kidney disease, stage 4 or 5 or receiving dialysis
Weight < 40 kg
Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
Known hepatic disease (cirrhosis, hepatitis)
Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
On immunosuppressive drugs steroids, antirejection medications.
Recipient of solid organ transplant
Pregnancy/breastfeeding
Past medical history Porphyria (may exacerbate disease)
PMH Psoariasis (can worsen disease)
No access to internet or email
Current suicidal thoughts according to Columbia scale
In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ

Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
Eligibility criteria:
Inclusion Criteria for Group A and B

Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria

Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE
Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period
Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period
Willing and able to provide informed consent

Exclusion Criteria for Group A only :

Known hypersensitivity to hydroxychloroquine or chloroquine
Known diagnosis of COVID-19

Concomitant use of

amiodarone
digoxin
flecainide
procainamide
propafenone
History of Torsades de pontes
History of retinal disease
Known chronic kidney disease ≥ stage 4
Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
Eligibility criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
Informed consent signed by patient

Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:

Occur up to ≤72h prior to informed consent of participation in the study
Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization.
Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment.
Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment.
Unable to take oral medications.
History of allergic reaction or intolerance to CQ or HCQ.
Baseline corrected qT interval >470 milliseconds (male) or >480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest.
Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide
History of retinal disease including a documented history of diabetic retinopathy.
Known history of G6PD deficiency.
Intervention: Duvelisib
Trial phase: Phase 2
ATC code: L01EM04
SMILES: C[C@H](Nc1ncnc2[nH]cnc12)c1cc2cccc(Cl)c2c(=O)n1-c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: -Duvelisib 25 mg twice daily for up to 10 days.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of advanced COVID-19 as defined both of the following:

as a positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (e.g. nasopharyngeal, nasal, oropharyngeal swab, or saliva) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab with an FDA approved assay.

Critical disease manifested by any of the following:

Chest imaging with ≥ 50% lung involvement
Respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (eg. BiPAPA, OptiFlow), supplementary oxygen with FiO2 ≥ 6 LPM or extracorporeal membrane oxygenation (ECMO)
Shock - defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support

Cardiac dysfunction defined by:

New global systolic dysfunction with ejection fraction ≤ 40%
Takotsubo cardiomyopathy
Patients who have received prior investigational or off-label agents for COVID-19 does not exclude eligibility.
At least 18 years of age at the time of study registration
Adequate hematologic function defined as absolute neutrophil count ≥1000/mm3 and platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening.
Creatinine-clearance ≥ 15 mL/minute or receiving renal replacement therapy
Aminotransferase (AST/ALT) levels <3x the upper limit of normal
Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
Male patients if engaging in sex with a women of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.

Exclusion Criteria:

Known allergy or intolerance to duvelisib or another PI3K inhibitor.
Known or suspected active viral (including CMV, HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. CMV viral load will be assessed at screening and those with viremia will be excluded. Other virologic testing not required unless infection is suspected.
Pregnant and/or breastfeeding.
Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
Intervention: IVERMECTIN
Trial phase: Phase 2
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Ivermectin
Eligibility criteria:
Inclusion Criteria

Age ≥18 years
Laboratory-confirmed SARS-CoV-2 infection within the past 7 days or the presence of symptoms or physical examination signs providing high probability of COVID-19 disease
Patients must have adequate organ and marrow function measured within the last 6 months

Subjects must have at least one of the following high-risk features for clinical deterioration:

Hypertension
Diabetes Mellitus
Moderate to severe Chronic Obstructive Pulmonary Disease, Emphysema, Cystic Fibrosis, or Asthma
Cancer patients who have received any immunosuppressive drugs within a year from enrollment
Sickle Cell disease or thalessemia
Age > or = 50
BMI > or = 30
Living in a nursing home or long-term facility
Underlying serious heart condition as determined by the treating physician
Immunocompromised subject as defined by the treating physician or COVID-19 Telehealth Treatment Team

Exclusion Criteria

Severe or life threating COVID
Weight less than 45 kg.
Pregnant or breast-feeding females
Subjects on dialysis or with creatinine clearance < 45 ml/min
Existing DMID Toxicity Scale for Determining Severity of Adverse Events grade 3 or greater hepatic failure
Previously documented moderate or severe retinopathy or macular degeneration
Uncontrolled Seizure disorder
Prolonged QT, defined as QTc ≥470 milliseconds for men and as QTc ≥480 for women using Bazett's formula
Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial.
Currently receiving any study medications for other indications
Concurrent use of medication that would cause drug-drug interactions
Patients with psychiatric illness/social situations that would limit compliance
Intervention: IVERMECTIN
Trial phase: Phase 2
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.

(Single dose of STROMECTOL® tablets at 400mcg/kg)
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
Residents of the Pamplona basin ("Cuenca de Pamplona")
The patient should be aged 18 to 59 years
Negative pregnancy test for women of child bearing age*
The patient or his/her representative, have given consent to participate in the study.

The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)

Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)

Exclusion Criteria:

Known history of Ivermectin allergy
Hypersensitivity to any component of Stromectol®

COVID-19 Pneumonia

Diagnosed by the attending physician
Identified in a chest X-ray
Fever or cough present for more than 48 hours
Positive IgG against SARS-CoV-2 by rapid test
Age under 18 or over 60 years

The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):

Immunosuppression
Chronic Obstructive Pulmonary Disease
Diabetes
Hypertension
Obesity
Acute or chronic renal failure
History of coronary disease
History of cerebrovascular disease
Current neoplasm
Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.

Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Eligibility criteria:
Inclusion Criteria:

Male Veterans admitted to a VA hospital.
Age > 18
Hospitalized on an acute care ward with a diagnosis of COVID-19 contributing to hospitalization.
Positive RT-PCR assay for SARS-CoV-2 on a nasopharyngeal swab sample.
Severity of illness of level 3, 4 or 5 on the influenza severity scale (see Appendix A) at the time of randomization.
The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.

Exclusion Criteria:

History of severe hypersensitivity to degarelix or any component of their respective formulation.
History of congenital long QT syndrome or known history of prolonged QT interval corrected by the Fridericia correction formula (QTcF) > 500 msec on electrocardiogram performed at screening.
Planned discharge within 24 hours of treatment initiation.
Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Ongoing usage of a Class IA or Class III antiarrhythmic agent. At least 5 half lives must elapse since any prior use of a Class IA or III antiarrhythmic agent prior to administration of study drug.

--Baseline electrolyte abnormalities of Grade 3 or higher (based on CTCAE v5.0 criteria). Patients may be included if baseline electrolyte abnormalities are corrected to Grade 2 or lower prior to study drug administration.

Myocardial infarction in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease.
Enrollment in another investigational study within 30 days of Day 1.
Known psychiatric or substance abuse disorder that would interfere with the requirements of the trial.
Child-Pugh Class C liver disease.

Use of any of the following hormonal agents within Day 1 of treatment:

Androgen receptor antagonists or agonists within 4 weeks,
Ketoconazole or abiraterone acetate within 2 weeks,
Estrogens or progestins within 2 weeks,
Herbal products that contain hormonally active agents within 2 weeks.
Unwilling or unable to comply with the study protocol.
Any condition, which in the opinion of the investigator, would preclude participation in the trial.
Intervention: Bromhexine Hydrochloride
Trial phase: Phase 4
SMILES: CN(Cc1cc(Br)cc(Br)c1N)C1CCCCC1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: medical personnel at risk for COVID-19 infection with oral administration of Bromhexine hydrochloride

Bromhexine Hydrochloride: Medical personnel at risk for COVID-19 infection will receive study medication for 14 days
Eligibility criteria:
Inclusion Criteria:

Age of 18 years or more;
Negative test (PCR) for SARS-CoV-2 infection;
The absence of clinical manifestations of a respiratory infection;
Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2 infection;
Signed informed consent to participate in the study.

Exclusion Criteria:

Intolerance to Bromhexine hydrochloride;
Work out of contact with SARS-CoV-2 infection;
Non-compliance with the rules for the use of personal protective equipment when working with SARS-CoV-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the Ministry of Health of Russia and the internal orders of the Director General of Almazov NMRC, relevant to the dates of research);
Pregnancy and the period of breastfeeding;
Other circumstances that the researcher considers inappropriate to participate in this study
Intervention: IVERMECTIN
Trial phase: Phase 2
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
Signed Informed Consent.

Exclusion Criteria:

Patients with severe disease COVID-19.
Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
Recurrent urinary tract infections.
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
Pregnant or lactating patients
Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
Patients with a known allergy or hypersensitivity to dewormers.
Patients who are using an antioxidant supplement.
Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.
Intervention: Povidone iodine
Trial phase: Phase 2
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days

Povidone-Iodine: Gargle
Eligibility criteria:
Inclusion Criteria:

adult aged 18 years and above
able to understand instructions
Stage 1 COVID-19
< 5 days of illness or diagnosis

Exclusion Criteria:

Less than 18 years old
Unable to understand instructions
Stage 2 & 3 COVID-19
Respiratory symptoms or fever on admission
Abnormal chest radiograph or computed tomography (CT) findings on admission
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 222
Group description: Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis
Eligibility criteria:
Inclusion Criteria:

Subjects of either gender aged ≥ 50 years
Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
Any intraocular surgery or thermal laser within 3 months of trial entry.
Any prior thermal laser in the macular region, regardless of indication
Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
Previous therapeutic radiation in the region of the study eye
Any sign of diabetic retinopathy in either eye
Intervention: Hydroxychloroquine
Trial phase: Phase 1 | Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Group A: 0 health care workers who chose to take hydroxychloroquine

Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.

Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily
Eligibility criteria:
Inclusion Criteria:

Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are asymptomatic for known presenting symptoms of SARS-CoV-2:
UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI's will consider study enrollment of HCWs from other settings, for example certain outpatient clinics or inpatient units.
Are not positive for SARS-CoV-2 testing
Willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures
Willing and able to provide informed consent

Exclusion Criteria:

Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
Currently hospitalized
Symptomatic with subjective fever, cough, or sore throat
Current medications exclude concomitant use of HCQ, for example anti-arrhythmic agents, digoxin, cyclosporin, cimetidine, or tamoxifen.
Concomitant use of other anti-malarial treatment or chemoprophylaxis
History of retinopathy of any etiology
Psoriasis
Porphyria
Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100K)
Known liver disease
Known long QT syndrome
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period. There may be some exceptions to requiring a 30-day washout that will be evaluated by the Co-Investigators on a case by case basis.