anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sitagliptin
Trial phase: Phase 1
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Participants who received a single oral dose of sitagliptin 200 mg.
Eligibility criteria:
Inclusion Criteria:

Males or females who are 10 - 17 years of age
History of type 2 diabetes
Nonsmoker
No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

History of diabetic ketoacidosis
History of stroke, chronic seizures or major neurological disorder
Consumes alcohol
Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
Unable to swallow tablets
Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

Has an estimated creatinine clearance of less than or equal to 80 mL/min
Intervention: Vigabatrin
Trial phase: Phase 2
ATC code: N03AG04
SMILES: C=CC(N)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: CPP-109 vigabatrin tablets

CPP-109 vigabatrin: tablets, bid for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Able to understand the study and provide written informed consent.

Male or female at least 18 years of age.
Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for methamphetamine dependence as major diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
Provides at least one urine specimen which is positive for methamphetamine according to a rapid screening test.
Seeking treatment for methamphetamine dependence.
Have normal visual fields.
Be in generally good health based on history, physical examination and laboratory findings.
If female of childbearing potential, use acceptable contraceptive methods

Exclusion Criteria:

Has current dependence on any psychoactive substance other than methamphetamine, alcohol, nicotine, or cannabinoid or physiologic dependence on alcohol requiring medical detoxification.
Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory values.
Has history of serious cardiovascular reaction to methamphetamine.
Has clinically significant cardiovascular impairment, abnormal ECG or uncontrolled hypertension.
Be under court or other governmental agency (e.g. social services) mandate to obtain treatment or requiring outside urine monitoring.
Be enrolled in an opiate substitution treatment program within 2 months of randomization.
Has ever taken vigabatrin in the past.
Is pregnant or lactating.
Has clinically significant ophthalmologic disease, which would preclude safety monitoring, is undergoing treatment for ocular disease or intends to have any ocular surgery or procedure performed during the time of their participation in the trial.
Has received a drug with known major organ toxicity, including retinotoxicity.
Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol.
Intervention: Drotaverine hydrochloride
Trial phase: Phase 3
SMILES: CCOc1ccc(C=C2NCCc3cc(OCC)c(OCC)cc32)cc1OCC.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 650
Group description: Drotaverine hydrochloride
Eligibility criteria:
Inclusion Criteria:

All patients undergoing ERCP above the age of 18 years

Exclusion Criteria:

Patient with Billroth II gastrectomy
Known previous sphincterotomy
Active acute pancreatitis before ERCP
Ongoing acute cholangitis before ERCP
Hypotension (systolic blood pressure < 100 mmHg)
Second-degree and third-degree atrioventricular block
Heart failure
Glaucoma
Obstructive uropathy
Impaired renal function (serum creatinine > 133μmol/L)
Pregnant or breastfeeding women
Intervention: Scopolamine butylbromide
Trial phase: Phase 3
SMILES: CCCC[N+]1(C)C2CC(OC(=O)C(CO)c3ccccc3)CC1C1OC12.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 650
Group description: Hyoscine-N-butylbromide
Eligibility criteria:
Inclusion Criteria:

All patients undergoing ERCP above the age of 18 years

Exclusion Criteria:

Patient with Billroth II gastrectomy
Known previous sphincterotomy
Active acute pancreatitis before ERCP
Ongoing acute cholangitis before ERCP
Hypotension (systolic blood pressure < 100 mmHg)
Second-degree and third-degree atrioventricular block
Heart failure
Glaucoma
Obstructive uropathy
Impaired renal function (serum creatinine > 133μmol/L)
Pregnant or breastfeeding women
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 309
Group description: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Eligibility criteria:
Inclusion Criteria:

Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
Colonoscopy within 2 years as part of IBS diagnostic evaluation.
Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

Symptoms of constipation.
History of other gastrointestinal diseases.
Type 1 or 2 diabetes.
Lactose intolerance not controlled by lactose-free diet.
Intervention: Citalopram
Trial phase: Phase 2 | Phase 3
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 160
Group description: Escitalopram

Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
Eligibility criteria:
Inclusion Criteria:

Non-Drug Abusing Control Subjects: Male and female subjects age 18 to 55 who do not meet current or past DSM-IV criteria for any Axis I disorder including substance abuse or dependence.
Cocaine Dependent Subjects: Male and female subjects age 18 to 55 who meet current DSM-IV criteria for cocaine dependence.
Female subjects: a negative pregnancy test.

Exclusion Criteria:

Non-Drug Abusing Control Subjects:

Current or past DSM-IV Axis I disorder
Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
Positive HIV test.
For female subjects: a positive pregnancy test or breast feeding.
Concomitant use of prescription medications that could affect the central nervous system.
Active suicidal ideation.
Hamilton Depression or Anxiety Scale score greater than 15

Cocaine Dependent Subjects:

Current DSM-IV Axis I disorder other than substance abuse/dependence
Current diagnosis of other substance dependence besides cocaine.
Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
Positive HIV test.
For female subjects: a positive pregnancy test or breast feeding.
Concomitant use of prescription medications that could affect the central nervous system.
Active suicidal ideation.
Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
Subjects with cardiac arrythmias.
Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
Hamilton Depression or Anxiety Scale score greater than 15.
Current alcohol abuse or dependence.
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 4
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 42
Group description: All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
Eligibility criteria:
Inclusion Criteria:

Females of child-bearing potential must have a negative pregnancy test.
Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
The subject and subject's parent or legal guardian must be willing and able to comply with all the testing and dosing requirements in this study.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
All subjects and their parents must be able to communicate effectively in English with the doctor and his/her staff without the aid of an interpreter.

Exclusion Criteria:

Subject has any documented, current, controlled psychiatric illness [except Oppositional Defiant Disorder (ODD)]. The child may continue participating in a behavior modification program during this study as long as he/she has been participating in the program for at least one month at the time of the baseline visit.
Subject has Conduct Disorder (CD).
Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
Subject has a history of heart abnormalities that the study doctor feels would exclude him/her from the study.
Subject has a positive urine drug result at the screening visit.
Subject weighs less than 50 pounds (22.7 kg).
Subject has taken another investigational drug within the last 30 days prior to the screening visit.
Subject has any reported history of abnormal thyroid function.
Subject has any clinically significant electrocardiogram reading (an electrical recording of the heart - ECG) or laboratory abnormalities at the screening and/or baseline visits.
The study doctor feels that the subject's safety would be jeopardized if entered in this study due to a current illness or medical condition. Mild, stable asthma is not exclusionary.
Subject is taking any medication that is excluded.
Intervention: Etoricoxib
Trial phase: Phase 4
ATC code: M01AH05
SMILES: Cc1ccc(-c2ncc(Cl)cc2-c2ccc(S(C)(=O)=O)cc2)cn1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Active study drug:

Etoricoxib 90 mg once daily
Eligibility criteria:
Inclusion Criteria:

Health ASA 1-2 patients 18-65 years of age

Exclusion Criteria:

ASA/NSAID allergy
Renal disease
Lithium therapy
Complicated cardiovascular disease
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 4
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: clobetasol propionate spray 0.05%
Eligibility criteria:
Inclusion Criteria:

Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
Subjects whose psoriasis involves only the scalp, face or groin
Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
Intervention: CLOBETASOL PROPIONATE
Trial phase: Phase 4
ATC code: D07AD01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: clobetasol propionate ointment 0.05%
Eligibility criteria:
Inclusion Criteria:

Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
Subjects whose psoriasis involves only the scalp, face or groin
Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
Intervention: Amphetamine
Trial phase: Phase 1 | Phase 2
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Eligibility criteria:
Inclusion Criteria:

Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
At least one cocaine positive urine during screening.
Current regular consumption of caffeine.
Female subjects: a negative pregnancy test.

Exclusion Criteria:

Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
Substance dependence other than cocaine within the last 3 months.
Positive breath alcohol.
Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
HIV positive.
I.Q. below 70.
Intervention: Nexium
Trial phase: Phase 4
SMILES: COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.O.O.O.[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 317
Group description: Open-label daily esomeprazole 40 mg, daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
informed consent
over 18 years of age

Exclusion Criteria:

Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
More than 1 other course of PPI treatment in the previous 12 month
previous use of esomeprazole
presence of alarm symptoms
Intervention: Anidulafungin
Trial phase: Phase 1
ATC code: J02AX06
SMILES: [H][C@@]1([C@@H](C)O)NC(=O)[C@H]([C@H](O)[C@@H](O)c2ccc(O)cc2)NC(=O)[C@@H]2C[C@@H](O)CN2C(=O)[C@H]([C@@H](C)O)NC(=O)[C@@H](NC(=O)c2ccc(-c3ccc(-c4ccc(OCCCCC)cc4)cc3)cc2)C[C@@H](O)[C@@H](O)NC(=O)[C@@H]2[C@@H](O)[C@@H](C)CN2C1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Eligibility criteria:
Inclusion Criteria:

Age < 24 months at the time of enrollment
Patient must have sufficient venous access to permit administration of study medication
Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

Patients with a history of anaphylaxis attributed to an echinocandin
Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
Previous participation in this study
Previous exposure to an echinocandin in the month prior to study.
Intervention: Fluconazole
Trial phase: Phase 3
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 188
Group description: fluconazole 6mg/kg IV or PO twice weekly for 6 weeks

fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses
Eligibility criteria:
Inclusion Criteria:

Informed consent from the legally authorized representative.
> 48 hours of age and < 120 hours old at time of first drug administration
< 750 g birth weight
Negative blood cultures for Candida

Exclusion Criteria:

History of a hypersensitivity or severe vasomotor reaction to any azole
receiving antifungal therapy for suspected/proven invasive fungal infection
medical condition, in the opinion of the Investigator, may create an unacceptable additional risk
diagnosed with invasive candidiasis or congenital Candida infection.
liver failure (AST and ALT > 250 U/L)
renal failure (creatinine > 2 mg/dL)
major lethal congenital or genetic anomalies
triplet or higher multiple gestations
Intervention: Nebivolol
Trial phase: Phase 4
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: 258
Group description: Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
Eligibility criteria:
Inclusion Criteria:

Male or female, ambulatory outpatients 18-85 years old at screening
Have a history of hypertension
Qualifying laboratory results

Exclusion Criteria:

Severe hypertension, including chronic kidney disease
Documented congestive heart failure
Have clinically significant respiratory, liver, or heart disease
History of stroke, heart attack, or heart surgery in the last 6 months
Have a history of hypersensitivity to nebivolol or other beta blockers.
Intervention: Nitrofurantoin
Trial phase: Phase 4
ATC code: J01XE01 | J01XE51
SMILES: O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 161
Group description: Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively

Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence
Eligibility criteria:
Inclusion Criteria:

Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion Criteria:

Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
Intervention: Mitomycin
Trial phase: Early Phase 1
ATC code: L01DC03
SMILES: [H][C@]12N[C@@]1([H])CN1C3=C(C(=O)C(N)=C(C)C3=O)[C@@H](COC(N)=O)[C@]12OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Mitomycin C and Hyperthermia
Eligibility criteria:
Inclusion Criteria:

Non-muscle invasive transitional cell carcinoma (TCC) of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with Bacillus Calmette Guerin (BCG) solution); or
An inability to tolerate BCG
Age > 18
Eastern Cooperative Oncology Group(ECOG) Performance Status 0-2

Laboratory tests performed within 14 days of study enrollment:

Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal *(ULN), Asparate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN
Women of child bearing potential must have a negative pregnancy test
If post-menopausal - Amenorrhea for ≥ 12 months

Exclusion Criteria:

Pregnancy or breastfeeding
Muscle invasive disease (T2-T4)
Prior radiation to the pelvis
Peripheral neuropathy (any grade)
Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
Known bladder fistula
Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past
Intervention: Maraviroc
Trial phase: Phase 4
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Stable antiretroviral therapy for at least 12 months
Screening CD4+ T cell count below 350 cells/mm3
All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA)
All available plasma HIV RNA levels within past year below the level of detection. Isolated values that are detectable but < 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable.
> 90% adherence to therapy within the preceding 30 days, as determined by self-report.
Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

Increase in CD4 count of > 100 cells/mm3 in past year.
Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
HBVsAg+ or active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
Prior exposure to CCR5 inhibitors
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.
Pregnant or breastfeeding women
Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.