anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cycloserine
Trial phase: Phase 2
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
Eligibility criteria:
Inclusion Criteria:

Must have a history of low back pain for a minimum of 6 months with or without radiation of pain to leg or buttocks.
Must be 18 years of age.
Must have a visual analogue scale (VAS) pain score >50 mm
Must be in generally stable health
Must be willing to abstain from drinking alcohol during the course of the study.
If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue either during the course of the study.
Must be able and willing to read and understand instructions as well as questionnaires
Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion Criteria:

Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
Neurologic disorder, including history of seizures
Major psychiatric disorder during the past 6 months
Moderate or severe depression as determined by the Beck Depression Inventory or any active suicidal ideation
Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
Significant renal disease or severe renal insufficiency
History of, or current, substance abuse/dependence including alcohol
Significantly abnormal laboratory values
Pregnant or lactating at any time during the course of the study
Known sensitivity to D-cycloserine
Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
Any change in medication for back pain in the last 30 days.
Intervention: Sildenafil
Trial phase: Phase 4
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Sildenafil x 45 days

sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
Eligibility criteria:
Inclusion Criteria:

Congenital diaphragmatic hernia
10-42 days (d) of age
Significant illness severity as demonstrated by:

Receiving assisted ventilation and

FiO2 >= 0.40 at 10-14d of age, or
FiO2 >= 0.40 for >=48hours at 15-27d of age, or
FiO2 >= 0.35 at 28-42d of age
Or, need for extracorporeal support at >=10d of age
Or, estimated pulmonary arterial or right ventricular systolic pressure of >= 2/3 systemic pressure at 14-42d of age

Exclusion Criteria:

Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect [ASD] or non-hemodynamically significant ventricular septal defect [VSD])

Sildenafil contraindicated (until condition resolves):

Unable to absorb oral medication, or
Unstable systemic blood pressure, or
Receiving a drug that may interfere with sildenafil metabolism, or
Renal insufficiency
Hepatic insufficiency Previous use of sildenafil
Intervention: Zoledronic acid
Trial phase: Phase 3
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: Female
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 613
Group description: Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
Eligibility criteria:
Inclusion Criteria:

Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

Poor kidney, eye, or liver health
Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Zoledronic acid
Trial phase: Phase 3
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: Female
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 1221
Group description: Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
Eligibility criteria:
Inclusion Criteria:

Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

Poor kidney, eye, or liver health
Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Participants received asenapine as a fast-dissolving SL tablet, BID. On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
Eligibility criteria:
Inclusion Criteria:

Have bipolar I disorder, current episode manic or mixed
Treated with lithium or valproic acid

Exclusion Criteria:

Have an unstable medical condition
Clinically significant laboratory abnormality.
Have a primary diagnosis other than bipolar I disorder.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 244
Group description: 5-10 mg sublingually twice daily for up to 26 weeks
Eligibility criteria:
Inclusion Criteria:

Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
Caregiver required.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition.
Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Subjects received open-label Levetiracetam.
Eligibility criteria:
Inclusion Criteria:

Subjects with a confirmed diagnosis of epilepsy.
Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
Male/female subjects (>= 16 years).

Exclusion Criteria:

- Need for an additional Antiepileptic Drug (AED).
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
Eligibility criteria:
Inclusion Criteria:

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
Eligibility criteria:
Inclusion Criteria:

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
Eligibility criteria:
Inclusion Criteria:

Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

Patients with unstable medical conditions or clinically significant laboratory

abnormalities.
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: Subjects received open-label Levetiracetam.
Eligibility criteria:
Inclusion Criteria:

Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.

Exclusion Criteria:

Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
Presence of known pseudoseizures within the last year.
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: 5-10 mg sublingually twice daily for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant

medical condition.

Have been judged to be medically noncompliant in the

management of their disease.
Intervention: Istradefylline
Trial phase: Phase 3
ATC code: N04CX01
SMILES: [H]/C(=C(/[H])c1nc2c(c(=O)n(CC)c(=O)n2CC)n1C)c1ccc(OC)c(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 503
Group description: Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Completion of study 6002-INT-001
Not of childbearing potential

Exclusion Criteria:

Cancer within 5 years of enrollment
ALT/AST levels > 2.5 times ULN
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Degarelix 120 mg (20 mg/mL)
Eligibility criteria:
Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Degarelix 240 mg (60 mg/mL)
Eligibility criteria:
Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Degarelix 320 mg (60 mg/mL)
Eligibility criteria:
Inclusion Criteria:

Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Intervention: Rebamipide
Trial phase: Phase 2
ATC code: A02BX14
SMILES: O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: 0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.
Intervention: Rebamipide
Trial phase: Phase 2
ATC code: A02BX14
SMILES: O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: 1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.
Intervention: Rebamipide
Trial phase: Phase 2
ATC code: A02BX14
SMILES: O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Outpatient.
Subjective complaint of dry eye that has been present for minimum 20 months.
Primary ocular discomfort severity is moderate to severe.
Corneal - conjunctival damage is moderate to severe.
Unanesthetized Schirmer's test score of 7mm/5minutes or less.
Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
Anticipated use of contact lens during the study.
Any history of ocular surgery within 12 months.
Female patients who are pregnant, possibly pregnant or breast feeding;
Known hypersensitivity to any component of the study drug or procedural medications.
Receipt of any investigational product within 4 months.
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 4
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
Eligibility criteria:
Inclusion Criteria:

Received kidney transplant
Receiving immunosuppressive regimen that includes MMF
Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
At least 18 years of age
Willing to provide written informed consent
Able to meet all study requirements including completing questionnaires and completing four study visits.

Exclusion Criteria:

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including, but not limited to, visual problems or cognitive impairment.
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Additional protocol-defined inclusion/exclusion criteria may apply.
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Has completed study treatment in study FE200486 CS02.
Has completed visit 16 in study FE200486 CS02.
Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
Intervention: Valganciclovir
Trial phase: Phase 4
ATC code: J05AB14
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 900mg PO qd

Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Eligibility criteria:
Inclusion Criteria:

Infection with HIV >1 year in duration.
Age >18
Cytomegalovirus (CMV) antibody positive.
All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3

On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months.

90% adherence to antiretroviral therapy within the preceding 30 days.
Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period.
Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10%

Exclusion Criteria:

Patients intending to modify antiretroviral therapy in the next 16 weeks.
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
Evidence of active symptomatic CMV end-organ disease.
Treatment with valganciclovir or ganciclovir in the past 30 days.
Concurrent treatment with immunomodulatory drugs.
Concurrent treatment with nephrotoxic drugs
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute.
Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis.
Pregnant or breastfeeding women