anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Humulin N
Trial phase: Phase 4
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Subjects are given a one-time, single dose of intranasal insulin
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
Male or female
Stable dose of the current antipsychotic drug for at least one month
Well established compliance with out-patient treatment per treating clinician's judgement.
Able to complete the cognitive assessment battery (must be English speaking)

Exclusion Criteria:

Inability to provide informed consent
Current substance abuse
On clozapine or olanzapine
Psychiatrically unstable per treating clinician's judgement.
Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.
Incapable to complete the cognitive battery assessment.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Sedative

Midazolam : sedative
Eligibility criteria:
Inclusion Criteria:

Healthy, human volunteers, age 19-65.
American Society of Anesthesiology (ASA) class I-II for inclusion criteria

Exclusion Criteria:

Pregnancy
Respiratory disease (severe asthma, emphysema)
Cardiac disease (coronary artery disease, congestive heart failure)
Symptomatic reflux disease
Advanced rheumatic disease involving cervical spine
Propofol or egg allergy
Neurological disease (stroke, intracranial processes)
Severe anemia
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: active drug

propofol : sedative
Eligibility criteria:
Inclusion Criteria:

Healthy, human volunteers, age 19-65.
American Society of Anesthesiology (ASA) class I-II for inclusion criteria

Exclusion Criteria:

Pregnancy
Respiratory disease (severe asthma, emphysema)
Cardiac disease (coronary artery disease, congestive heart failure)
Symptomatic reflux disease
Advanced rheumatic disease involving cervical spine
Propofol or egg allergy
Neurological disease (stroke, intracranial processes)
Severe anemia
Intervention: Simvastatin
Trial phase: Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Simvastatin: 80mg simvastatin oral once daily for 24 months
Eligibility criteria:
Inclusion Criteria:

Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point on the EDSS or clinical documentation of increasing disability.
EDSS 4.0 - 6.5 inclusive
Women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
Able to give written informed consent
18 - 65 years

Exclusion Criteria:

Unable to give informed consent
Primary progressive MS
Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. These patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period.
Patient is already taking or is anticipated to be taking a statin.
Any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
The use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
The use of mitoxantrone if treated within the last 12 months.
If the patient has ever been treated with alemtuzumab.
If screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients should be excluded.
Patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
If a female patient is pregnant or breast feeding
Intervention: Ferric citrate
Trial phase: Phase 2
ATC code: V03AE08
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[Fe+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)

Intent-to-Treat (ITT)
Eligibility criteria:
Inclusion Criteria:

Males and non-pregnant, nonlactating females
Age > 18 years
On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
Phosphorous levels ≥3.5mg/dL at Screening Visit
On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50%
Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex
Willing and able to give informed consent

Exclusion Criteria:

Parathyroidectomy within 6 months prior to Screening
Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
History of documented inflammatory bowel disease or erosive esophagitis
Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
History of multiple drug allergies
History of malignancy in the last 5 years (treated cervical or skin cancer may be permitted if approved by CCC)
Previous intolerance to oral ferric citrate
Absolute requirement for oral iron therapy
Absolute requirement for Vitamin C (multivitamins [Neprocaps, Renaphro, etc.] allowed)
Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
Inability to tolerate oral drug intake
Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
Receipt of any investigational drug within 30 days of randomization
Inability to cooperate with study personnel or history of noncompliance
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants will take propranolol for 14 weeks.

Propanolol: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.

Cognitive therapy workbook: Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning symptom criteria), but not the avoidance/numbing symptom criteria

Exclusion Criteria:

Past or current asthma
Diabetes or heart disease
Currently pregnant or breastfeeding
Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed if dose has been stable for the 3 months before study entry
Exposure therapy or additional cognitive therapy during the course of the study (supportive psychotherapy is allowed if ongoing for at least 3 months before study entry)
Substance abuse
Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or digoxin
Intervention: Nebivolol
Trial phase: Phase 3
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
Eligibility criteria:
Inclusion Criteria:

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion Criteria:

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Intervention: Metoprolol Succinate
Trial phase: Phase 3
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1.COCCc1ccc(OCC(O)CNC(C)C)cc1.O=C(O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
Eligibility criteria:
Inclusion Criteria:

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion Criteria:

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Memantine tablets, twice a day (bid).
Eligibility criteria:
Inclusion criteria:

Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.
Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.
The patient should have German as a mother-tongue or at least speak the language fluently.

Exclusion criteria:

Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
Modified Hachinski Ischemia score greater than 4 at screening.
Intake of any medication that is contra-indicated in combination with memantine.
Treatment with depot antipsychotics.
History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.
Known or suspected history of alcoholism or drug abuse within the past 10 years.
Previous treatment with memantine or participation in an investigational study with memantine.
Intervention: EXENATIDE
Trial phase: Phase 2 | Phase 3
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated

Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day
Eligibility criteria:
Inclusion Criteria:

Well documented NASH based on clinical and histological criteria. Liver biopsy must have been obtained within 12-months prior to initiation of the study.
Subjects must have known diabetes (either diet controlled or only on Metformin or sulfonylureas such as glyburide or glipizide).
Subjects must be 18 year or older.

Exclusion Criteria:

Co-existing etiologies for chronic liver disease (hepatitis B or C, autoimmune or hemochromatosis, etc.).
Clinical or histological evidence of cirrhosis.
Alanine aminotransferase or aspartate aminotransferase > 300 IU/L.
Uncontrolled diabetes (hemoglobin A1C greater than or equal to 9%).
Insulin or TZD dependant DM.
Known human immunodeficiency virus infection.
Current or history of significant alcohol consumption within past 5 years. Significant alcohol consumption is defined as >20 grm/day in females and >30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified.
Serum creatinine of greater than or equal to 2 mg/dl.
Active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years.
Current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin).
Use of drugs historically associated with NASH.
Histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease.
Active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year.
Known intolerance or allergy to exenatide (Byetta).
History of neuroglycopenia.
Women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period.
Women must not be nursing.
Intervention: Gadoteric acid
Trial phase: Phase 4
ATC code: V08CA02
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(CC(=O)O)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Dotarem®: Single IV administration before the MRI
Eligibility criteria:
Inclusion Criteria:

Male or female, > or equal 18 years ;
Patient with a known stable renal insufficiency ;
Patient scheduled to undergo an MRI examination to specify a diagnosis ;
Patient able to understand and provide written informed consent to participate in the trial ;

Exclusion Criteria:

Patient with a contra-indication to MRI ;
Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;
Patient who needs hemodialysis ;
Patient with known allergy to gadolinium chelates ;
Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;
Patients planned to either undergo surgery or receive chemotherapy ;
Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
Patient with newly discovered unstable diabetes.
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 3
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 207
Group description: fluticasone propionate nasal spray
Eligibility criteria:
Inclusion Criteria:

Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
Must be in generally good health
Must meet minimum symptom requirements, as specified in the protocol
Must be wiling and able to provide informed consent and to participate all study procedures
Positive skin test to a prevalent spring allergen

Exclusion criteria:

On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
Nasal or sinus surgery within the previous 6 months
Chronic sinus infection (more than 3 per year)
Planned travel outside the study area during the study period
Use of any investigational drug within 30 days of the first visit
Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
Women who are not using an acceptable method or birth control
Women who are pregnant or nursing
Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
Irregular heartbeat or other symptomatic heart conditions
History of alcohol or drug abuse
History of glaucoma
Use of medications that could affect the study results
Intervention: Azelastine
Trial phase: Phase 3
ATC code: R01AC03 | R06AX19 | S01GX07
SMILES: CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 208
Group description: azelastine HCl nasal spray nasal spray
Eligibility criteria:
Inclusion Criteria:

Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
Must be in generally good health
Must meet minimum symptom requirements, as specified in the protocol
Must be wiling and able to provide informed consent and to participate all study procedures
Positive skin test to a prevalent spring allergen

Exclusion criteria:

On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
Nasal or sinus surgery within the previous 6 months
Chronic sinus infection (more than 3 per year)
Planned travel outside the study area during the study period
Use of any investigational drug within 30 days of the first visit
Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
Women who are not using an acceptable method or birth control
Women who are pregnant or nursing
Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
Irregular heartbeat or other symptomatic heart conditions
History of alcohol or drug abuse
History of glaucoma
Use of medications that could affect the study results
Intervention: Lopinavir
Trial phase: Phase 2
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: 21
Group description: Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
Eligibility criteria:
Inclusion Criteria:

Documented HIV Infection
Genotypic resistance without major resistance mutations within 30 days
Antiretroviral drug-naïve
Screening HIV-1 RNA ≥5000
Women of reproductive potential
Negative pregnancy test within 48 hours

Exclusion Criteria:

Acute or recent HIV-1 infection
Currently breast feeding
Use of immunomodulators
Evidence of major resistance mutations
HBsAg positive
Acute hepatitis of any etiology or clinically significant liver disease
Current imprisonment or involuntary incarceration
Intervention: Tenofovir
Trial phase: Phase 2
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
Eligibility criteria:
Inclusion Criteria:

Documented HIV Infection
Genotypic resistance without major resistance mutations within 30 days
Antiretroviral drug-naïve
Screening HIV-1 RNA ≥5000
Women of reproductive potential
Negative pregnancy test within 48 hours

Exclusion Criteria:

Acute or recent HIV-1 infection
Currently breast feeding
Use of immunomodulators
Evidence of major resistance mutations
HBsAg positive
Acute hepatitis of any etiology or clinically significant liver disease
Current imprisonment or involuntary incarceration