anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: rosuvastatin 20 mg
Eligibility criteria:
Inclusion Criteria:

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications
Intervention: Rosuvastatin
Trial phase: Phase 3
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 173
Group description: rosuvastatin open label
Eligibility criteria:
Inclusion Criteria:

Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

Certain medical conditions and lab test results
History of a reaction to rosuvastatin or other statin drugs
Use of specified disallowed medications
Intervention: Ampicillin/sulbactam
Trial phase: Phase 4
SMILES: CC1(C)C(C(=O)[O-])C2C(=O)CC2S1(=O)=O.CC1(C)SC2C(NC(=O)C(N)c3ccccc3)C(=O)N2C1C(=O)[O-].[Na+].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 372
Group description: patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
Eligibility criteria:
Inclusion Criteria:

Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.

Exclusion Criteria:

Ductal carcinoma in situ (DCIS; stage 0 cancer),
Advanced or distant metastatic stage,
Receiving any neoadjuvant therapy,
History of receiving any antibiotics within prior 3 months,
History of immunodeficiency,
Having a remote infection,
History of reaction to study antibiotics,
Denial of signing the consent form.
Intervention: Propranolol
Trial phase: Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Propranolol
Eligibility criteria:
Inclusion Criteria:

ISS>25, stable at 48 hours after injury
Fully resuscitated
Ventilated

Exclusion Criteria Include:

Intracranial hypertension requiring active treatment
Hypotension/Pressors
Already on beta blocker for a standard indication
Intervention: Itraconazole
Trial phase: Phase 3
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 581
Group description: Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of onychomycosis of at least one great toenail
Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit).
Length of Unaffected Part of the Target Toenail ≥2mm
Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail
Subjects must have signed informed consent
If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication.

Exclusion Criteria:

Onychomycosis caused by Candida spp. without the presence of a dermatophyte
Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1
Use of systemic antifungals within 12 weeks prior to Visit 1
Use of topical antifungal nail lacquer within 30 days prior to Visit 1
Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1
Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF
Known liver disease or a history of liver toxicity with other drugs
Use of systemic immunosuppressants
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6009
Group description: Nicotine Replacement Therapy plus Behavioural Intervention

Nicotine Replacement Therapy: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge

behavioural intervention: Smoking cessation counselling, relapse prevention strategies
Eligibility criteria:
Inclusion Criteria:

Subjects must be Ontario residents
Older than or equal to 18 years of age
Current daily smokers who smoke >10 cigarettes per day
Smoked more than 100 cigarettes in their lifetime

Exclusion Criteria:

Current treatment with Varenicline
Allergic to adhesive
Intolerant to Nicotine Replacement Therapy
Medical contraindications
Intervention: Potassium Citrate
Trial phase: Phase 4
ATC code: A12BA02
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[K+].[K+].[K+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Potassium Citrate 20 meq twice daily

potassium citrate: 20 meq by mouth in capsule form twice daily
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women, more than 2 years post menopause
Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and -2.5
No history of prior fragility fracture

Exclusion criteria:

Renal insufficiency
Use of potassium sparing diuretics
Use of potassium supplements
Hyperkalemia
Secondary causes of osteoporosis or metabolic bone disease
Delayed gastric emptying
esophageal compression, intestinal obstruction or stricture
use of anticholinergic medication
active urinary tract infection.
Intervention: Potassium Citrate
Trial phase: Phase 4
ATC code: A12BA02
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[K+].[K+].[K+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Placebo

potassium citrate: 20 meq by mouth in capsule form twice daily
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women, more than 2 years post menopause
Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and -2.5
No history of prior fragility fracture

Exclusion criteria:

Renal insufficiency
Use of potassium sparing diuretics
Use of potassium supplements
Hyperkalemia
Secondary causes of osteoporosis or metabolic bone disease
Delayed gastric emptying
esophageal compression, intestinal obstruction or stricture
use of anticholinergic medication
active urinary tract infection.
Intervention: Epinephrine
Trial phase: Phase 3
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 727
Group description: 1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Eligibility criteria:
Inclusion Criteria:

Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea
Age above 16 (Age 21 and above for CGH only)

Exclusion Criteria:

Traumatic cardiac arrest
Age 16 and below (Age 20 and below for CGH only)
CPR is contraindicated
Intervention: Pituitrin
Trial phase: Phase 3
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 727
Group description: 40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
Eligibility criteria:
Inclusion Criteria:

Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea
Age above 16 (Age 21 and above for CGH only)

Exclusion Criteria:

Traumatic cardiac arrest
Age 16 and below (Age 20 and below for CGH only)
CPR is contraindicated
Intervention: Lopinavir
Trial phase: Phase 3
ATC code: J05AR10
SMILES: Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 300
Group description: lopinavir/ritonavir 800/200 mg once daily (QD) tablet
Eligibility criteria:
Inclusion Criteria:

Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening and were not acutely ill.
Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy
Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams per deciliter.
Subjects were excluded if screening laboratory analyses showed absolute neutrophil count <= 750 cells/microliter.
Subjects were excluded if screening laboratory analyses showed platelet count <= 50,000 per cubic millimeter.
Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of normal (ULN).
Intervention: Lopinavir
Trial phase: Phase 3
ATC code: J05AR10
SMILES: Cc1cccc(C)c1OCC(=O)N[C@@H](Cc1ccccc1)[C@@H](O)C[C@H](Cc1ccccc1)NC(=O)[C@H](C(C)C)N1CCCNC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Eligibility criteria:
Inclusion Criteria:

Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening and were not acutely ill.
Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy
Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams per deciliter.
Subjects were excluded if screening laboratory analyses showed absolute neutrophil count <= 750 cells/microliter.
Subjects were excluded if screening laboratory analyses showed platelet count <= 50,000 per cubic millimeter.
Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of normal (ULN).
Intervention: Montelukast
Trial phase: Not Applicable
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: subjects received study drug montelukast, 10 mg once per day
Eligibility criteria:
Inclusion Criteria:

A subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:

Male or female with no health concerns that might affect the outcome of the study
Age 18-65 range
diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
a history of asthma for at least six months prior to screening
FEV1> 80% of predicted
presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
ability to produce sputum when induced during the baseline assessments
asthma medications consisting of only inhaled short acting B-agonist taken as needed
reversible airways disease as indicated by > 12% reversibility post B-agonist or
methacholine hyperresponsiveness (PC20 < 8 mg/ml)
ability to give valid informed consent to participate by signing and dating a written consent form

Exclusion Criteria:

A subject is not eligible to participate in this study if any of the following exclusion criteria apply:

History of severe episodes of asthma with respiratory infections
Screening serum RV16 antibody titer > 1
Current smoker or has a smoking history exceeding 5 pack years
Currently receiving immunotherapy
Currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
Unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial
Pregnant or breast-feeding or has a planned pregnancy during the course of the study
Regular use of an asthma controller such as montelukast or an inhaled corticosteroid.
Intervention: RESEQUINIL
Trial phase: Phase 2
SMILES: COc1cccc(-c2nccc3[nH]c(=O)c(-c4noc(C)n4)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: AC-3933, 5mg twice daily
Eligibility criteria:
Inclusion Criteria:

Mild to moderate Alzheimer's Disease
Male or female 55 years or older
Living with caregiver
Read, understand and speak English

Exclusion Criteria:

Need to drive during the study
Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
Frequent Smoker
Frequent Consumer of Caffeine
Intervention: RESEQUINIL
Trial phase: Phase 2
SMILES: COc1cccc(-c2nccc3[nH]c(=O)c(-c4noc(C)n4)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: AC-3933, 20 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Mild to moderate Alzheimer's Disease
Male or female 55 years or older
Living with caregiver
Read, understand and speak English

Exclusion Criteria:

Need to drive during the study
Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
Frequent Smoker
Frequent Consumer of Caffeine
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 3
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Eligibility criteria:
Inclusion Criteria:

Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception

Exclusion Criteria:

Post menopausal menstrual cycle < 21 days or > 35 days
Pregnancy
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 108
Group description: 80mg of atorvastatin given once daily for 16 weeks
Eligibility criteria:
Inclusion Criteria:

18+ years old
Normocholesterolemic

Exclusion Criteria:

Cardiovascular disease or risk equivalents
Malignancy
Active alcohol abuse
Contraindications to statins
Interacting drugs
Chronic anti-inflammatory drugs
Intervention: Mometasone
Trial phase: Phase 4
ATC code: D07AC13 | R01AD59 | R03AK14 | R03AL12
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Active intranasal steroid therapy daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Males and females between 18 and 59 years of age.
Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
Positive skin or RAST test to allergen.
Symptoms of olfactory dysfunction.
No significant history of chronic sinusitis.

Exclusion Criteria:

Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
Use of any other investigational agent in the last 30 days.
Absence of olfactory or nasal symptoms.
Use of medications that may affect olfaction.
Medical conditions that may affect olfaction.
Smoking.
URI at the time of screening.
Intervention: Tapentadol
Trial phase: Phase 3
ATC code: N02AX06
SMILES: CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 894
Group description: Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
Have a pain intensity >4 on Numerical Rating Scale

Exclusion Criteria:

Life-long history of seizure disorder or epilepsy
Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
Intervention: Oxycodone cr
Trial phase: Phase 3
SMILES: CNC1CCC23c4c5ccc(OC)c4OC2C(=O)CCC3(O)C1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
Have a pain intensity >4 on Numerical Rating Scale

Exclusion Criteria:

Life-long history of seizure disorder or epilepsy
Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
Intervention: Lansoprazole
Trial phase: Phase 2 | Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
Eligibility criteria:
Inclusion Criteria:

chronic cough consistent with bronchoreactivity
Gastroesophageal reflux

Exclusion Criteria:

Severe asthmatics who have been hospitalized within the last 6 months or who have required oral steroid use within the last 4 weeks
Severe coronary artery disease
Cigarette/cigar smoking within the last 6 months
Documented allergies affecting the respiratory system

Subjects with contraindications to pH/impedance probe

Hemophilia
Septal deviation
Subjects with contraindications to bronchoscopy as outlined by the American Thoracic Society Guidelines
Anticoagulation
Pregnancy
Incarcerated patients
Current oral steroid use (may suppress levels of inflammation)
Upper respiratory infection within the last 2 weeks
Ongoing acid suppression with a proton pump inhibitor, however, patients may be included if they have discontinued their proton pump inhibitor within the last 1 month with stable asthma symptoms as defined by stable utilization of inhaled steroids
Intervention: Ritonavir
Trial phase: Phase 3
ATC code: J05AE03 | J05AE30 | J05AP52 | J05AP53 | J05AR10 | J05AR23 | J05AR26
SMILES: CC(C)c1nc(CN(C)C(=O)N[C@H](C(=O)N[C@@H](Cc2ccccc2)C[C@H](O)[C@H](Cc2ccccc2)NC(=O)OCc2cncs2)C(C)C)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
Eligibility criteria:
Inclusion criteria:

Subjects with HIV-1 infection.
Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria:

Are pregnant or breastfeeding.
Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
Have certain medical conditions that may make participation unsafe.
Take medication that may interact with the study medication.
Have a history of allergy to any of the study drugs or any excipients therein.
Other inclusion/exclusion criteria to be evaluated by the physician.