anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
Eligibility criteria:
Inclusion Criteria:

The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
The patient is willing to be hospitalised from the Screening Visit through Week 6.
The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
The patient has a history of neuroleptic malignant syndrome.
The patient has any relevant medical history or current presence of systemic disease.
The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 209
Group description: 210 were enrolled, only 209 patients were treated with brexpiprazole
Eligibility criteria:
Inclusion Criteria:

The patient has completed the lead-in study 14644A.
The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
The patient has a clinically significant unstable illness diagnosed during Study 14644A.
The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Intervention: Tilarginine
Trial phase: Phase 4
SMILES: CNC(=N)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ 20 and <80 years of age
Patients who have non-malignant chronic pain(≥90 days)
Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
Patients who signed a written informed consent form

Exclusion Criteria:

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
Intervention: Tilarginine
Trial phase: Phase 4
SMILES: CNC(=N)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 128
Group description: Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ 20 and <80 years of age
Patients who have non-malignant chronic pain(≥90 days)
Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
Patients who signed a written informed consent form

Exclusion Criteria:

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
Intervention: Mexiletine
Trial phase: Phase 4
ATC code: C01BB02
SMILES: Cc1cccc(C)c1OCC(C)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Mexiletine, capsule, 150mg, PO BID, 14 days

Mexiletine: Sodium channel blocker
Eligibility criteria:
Inclusion Criteria:

ALS diagnosed according to El Escorial criteria (Awaji version) as: Possible, Probable, or Definite.
Experiencing cramps as a moderate or severe symptom as defined by willingness to take a medication for the symptom
≥2 cramps per week during run in week
Life expectancy > 6 months, estimated by clinician
Able to take drug capsule by mouth
No significant EKG abnormality on screening
aspartate aminotransferase / alanine aminotransferase <2x upper limit of normal measured at screening
Having successfully filled out the cramp diary and cramp and fasciculation scales on six out of the last seven days of run in period

Exclusion Criteria:

Inability to communicate by telephone or email
Allergy/ known sensitivity to mexiletine
Prior use of mexiletine
AV block unless subject has pacemaker
Cardiac arrhythmia
Prior myocardial infarction
Other significant EKG abnormality
Liver disease
History of leucopenia (WBC <3,500/mm3)
Epilepsy
Other serious and unstable medical condition
Pregnant woman
Breastfeeding woman
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Use of quinidine (alone or as a component of Nuedexta®) during the study
Inability or unwillingness of subject to give written informed consent
Woman of childbearing potential, not willing to use at least two approved methods of contraception
Use of a prohibited medication during study
Intervention: Pradigastat
Trial phase: Phase 2
SMILES: O=C(O)C[C@H]1CC[C@H](c2ccc(-c3ccc(Nc4ccc(C(F)(F)F)nc4)cn3)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Eligibility criteria:
Inclusion Criteria:

History of liver steatosis during the preceding 24 months
History of fasting TGs > 200 mg/dL (confirmed at screening).
Liver fat ≥ 10% as determined by the central MRI laboratory.

Subjects on the following medications can be included if these medications are medically necessary, cannot be stopped and the investigator feels their dose will remain stable for the duration of the double-blind treatment period:

Stable dose of anti-diabetic medications (metformin and/or sulfonylureas) for at least 8 weeks prior to screening.
Stable doses of beta-blockers and thiazide diuretics for at least 8 weeks prior to screening.
Stable doses of fibrates, statins, niacin, ezetimibe for at least 8 weeks prior to screening.
Stable dose of vitamin E in patients taking >200 IU/day for at least 6 months prior to screening.

Exclusion Criteria:

Treatment with omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day within 8 weeks of screening.
Treatment with antiretrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within 8 weeks of screening.
ALT or AST > 250 IU/L at the time of screening.
History/current evidence of heavy alcohol use or alcoholism (> 21 drinks per week in men and > 14 drinks per week in women) over a 2-year period prior to screening.
Presence of chronic liver disease, such as chronic hepatitis B and/or C, alcoholic liver disease, hemochromatosis, Wilson's disease, known cirrhosis.
Platelet count <150,000 at screening.
BMI >45 Kg/m2.

Other protocol defined inclusion/exclusion criteria may apply
Intervention: Nitroglycerin
Trial phase: Phase 2
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Glycerly Trinitrate (Nitroglycerine) 5mg/24hour (0.2mg/hour) transdermal

Glycerly Trinitrate: 5mg/24hour (0.2mg/hour) transdermal
Eligibility criteria:
Inclusion Criteria:

Suspected stroke identified with Los Angeles Prehospital Stroke Screen
Age 40-80, inclusive
Last known well time within 2 hours of treatment initiation
Deficit present for > 15 minutes
Systolic blood pressure ≥180

Exclusion Criteria:

Coma
Rapidly improving neurologic deficit
Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or > 24)
Major head trauma in the last 24 hours
Recent stroke within prior 30 days
Use of erectile dysfunction therapies in the previous 12 hours
Use of type V phosphodiesterase inhibitors
Patient unable to give informed consent and no available legally authorized representative (LAR) to provide informed consent
Intervention: Empagliflozin/metformin
Trial phase: Phase 1
SMILES: CN(C)C(=N)N=C(N)N.COC1OC(c2ccc(Cl)c(Cc3ccc(OC4CCOC4)cc3)c2)C(O)C(O)C1O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: fixed-dose-combination tablet, oral with 240 ml water under fasted conditions

Empagliflozin/Metformin: medium dose of Empagliflozin oral administration
Eligibility criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Intervention: Empagliflozin/metformin
Trial phase: Phase 1
SMILES: CN(C)C(=N)N=C(N)N.COC1OC(c2ccc(Cl)c(Cc3ccc(OC4CCOC4)cc3)c2)C(O)C(O)C1O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Empagliflozin/Metformin: medium dose of Empagliflozin oral administration
Eligibility criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Intervention: Empagliflozin/metformin
Trial phase: Phase 1
SMILES: CN(C)C(=N)N=C(N)N.COC1OC(c2ccc(Cl)c(Cc3ccc(OC4CCOC4)cc3)c2)C(O)C(O)C1O.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Empagliflozin/Metformin: low dose of Empagliflozin
Eligibility criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Dexamethasone 8 mg IV given intraoperatively as a one-time dose.

Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiology (ASA) class 1, 2 and 3
Gestational age > 37 weeks
scheduled for elective cesarean delivery
spinal or combined spinal epidural anesthesia
18 years or older
speak English

Exclusion Criteria:

BMI > 45 kg/m2
Diabetes Mellitus (Type 1, 2 and gestational)
mild or severe preeclampsia
history of intravenous drug or opioid abuse
previous history of chronic pain syndrome
history of opioid use in the past week
receipt of an antiemetic within 24 h prior to surgery
Non-English speaking
Intervention: Mavoglurant
Trial phase: Phase 2
SMILES: COC(=O)N1CC[C@@H]2[C@H]1CCC[C@@]2(O)C#Cc1cccc(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
Eligibility criteria:
Inclusion Criteria:

Male and female , non-smokers patients aged between 18 to 65 years (inclusive),
A primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR 4th ed, year 2000), as confirmed by an Independent Rater.
Be on a stable appropriate dose of selective serotonin reuptake inhibitor (SSRI) treatment for at least 12 weeks prior to Baseline.
Have an insufficient response to current SSRI treatment (as per Inclusion Criterion 4) and confirmed by an Independent Rater.
Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of score ≥ 16 at Screening (and confirmed by an Independent Rater).
Patient must have their eligibility confirmed following the remote interview conducted by the Independent Rater.
Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

Diagnosis of primary OCD symptom of hoarding.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception (not including oral contraceptives) during dosing and for 30 days after last dosing of study medication.
History of more than two unsatisfactory trials with different SSRI within a period of 2 years prior to screening (not including the current treatment with SSRI's given in an adequate dose for at least 12 weeks).
Diagnosed with any primary DSM-IV-TR Axis I disorder other than OCD (as confirmed by an Independent Rater); with the exception of depression.
History of eating disorder (e.g. anorexia, bulimia) according to DSMIV within the last 6 months prior to Screening, (as confirmed by an Independent Rater).
Diagnosed with antisocial personality disorder (DSM-IV-TR Axis II), as confirmed by an Independent Rater.
Has current or past medical history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, within the last 6 months prior to Screening.
Smokers (use of tobacco products in the previous 3 months).
History of hallucinations/psychosis that would require antipsychotic treatment or DSM-IV criteria being met
Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non- Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
Intervention: Tranexamic acid
Trial phase: Phase 1 | Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.

Tranexamic Acid: Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:

placebo i.e. saline 0.9% (intravenous injection)
intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery.
Eligibility criteria:
Inclusion Criteria:

Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.

Exclusion Criteria:

Preexisting coagulopathy, (INR>1.4, PTT>1.4xN, PT>1.4xN, platelet count<150,000/mm3), severe hematological disorders, hepatic failure, or renal failure. Ingestion of acetylsalicylate within 14 days or NSAIDs within 2 days of the scheduled surgery date; history of prior blood transfusion. Pre-donation of autologous blood. Patients having anterior-posterior repair.
Intervention: Rosuvastatin
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Rosuvastatin 20mg daily

Rosuvastatin: encapsulated tablet 20mg daily
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
HIV positive
Stable combination anti-retroviral therapy (cART) with plasma HIV viral load <200copies/ml for ≥ 6 months

Exclusion Criteria:

Recommended use of lipid lowering therapy according to Australian guidelines
Prior use of statin, fibrate, ezetimibe within the last six months
Contraindication to statin use
Intervention: delta-(L-alpha-Aminoadipoyl)-L-cysteinyl-glycine
Trial phase: Phase 4
ATC code: G03GA01
SMILES: NC(CCCC(=O)NC(CS)C(=O)NCC(=O)O)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger

hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Eligibility criteria:
Inclusion Criteria:

Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000 pg/mL on the day of trigger of oocyte maturation.

Exclusion Criteria:

Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum E2 levels >= 4,000 pg/mL.
Intervention: delta-(L-alpha-Aminoadipoyl)-L-cysteinyl-glycine
Trial phase: Phase 4
ATC code: G03GA01
SMILES: NC(CCCC(=O)NC(CS)C(=O)NCC(=O)O)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.

hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Eligibility criteria:
Inclusion Criteria:

Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000 pg/mL on the day of trigger of oocyte maturation.

Exclusion Criteria:

Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum E2 levels >= 4,000 pg/mL.
Intervention: Bivalirudin
Trial phase: Phase 4
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 105
Group description: Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.

Atripla or Stribild: Antiretroviral therapy
Eligibility criteria:
Inclusion Criteria:

Adult men who have sex with men, and transgender women
Unaware of HIV status at enrollment in follow-up cohort
High risk for HIV infection
Willing to test for HIV
No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days
Willing to provide informed consent

Exclusion Criteria:

Prior receipt of investigational anti-HIV vaccine

Ongoing therapy with any of the following:

Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed
Systemic chemotherapeutic agents
Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine
Immunomodulatory treatments including Interleukin-2
Investigational agents
Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
Active drug or alcohol use or dependence that would interfere with adherence to study requirements
Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
Chronic or acute hepatitis B infection
Use of female hormonal products based on estrogen or derivatives