------------------------- README.ntis ACTG 320 ------------------------- --------------------------------------------------------------------- "A CONTROLLED TRIAL OF TWO NUCLEOSIDE ANALOGUES PLUS INDINAVIR IN PERSONS WITH HUMAN IMMUNODEFICIENCY VIRUS INFECTION AND CD4 CELL COUNTS OF 200 PER CUBIC MILLIMETER OR LESS" Scott M. Hammer, M.D., Kathleen E. Squires, M.D., Michael D. Hughes, Ph.D., Janet M. Grimes, M.S., Lisa M. Demeter, M.D., Judith S. Currier, M.D., Joseph J. Eron, Jr., M.D., Judith E. Feinberg, M.D., Henry H. Balfour, Jr., M.D., Lawrence R. Deyton, M.D., Jeffrey A. Chodakewitz, M.D., and Margaret A. Fischl, M.D., for the AIDS Clinical Trials Group 320 Study Team Published in the New England Journal of Medicine on September 11, 1997 ---------------------------------------------------------------------- The following nine data sets were used to produce the above publication. They are located in the SAS transport file: transport.ntis. ASCII versions of the nine datasets exist as well. They have .dat endings. (Included at the end of this file is the code from the program written which created the ascii files.) basedata.ssd01 cd4.ssd01 endpnt2.ssd01 labtox.ssd01 pcpid.ssd01 status.ssd01 strat.ssd01 symptom.ssd01 _rnap.ssd01 Below is a more complete contents listing for each of the nine data sets. 1) PCPID.SSD01 ************ # Variable Type Len Pos Label ----------------------------------------------------------- 1 INSTN Num 8 0 site of entry 3 PIDNUM Num 8 9 2 REG Char 1 8 randomized treatment REG Randomized treatment A=ZDV+3TC B=IDV+ZDV+3TC F=d4T+3TC G=IDV+d4T+3TC 2) STRAT.SSD01 *********** # Variable Type Len Pos Label ----------------------------------------------------------------- 2 PIDNUM Num 8 8 patient id number 1 STRAT2 Num 8 0 CD4 Stratum (0=<=50,1=>50) 3) CD4.SSD01 ********* # Variable Type Len Pos Format Label ----------------------------------------------------------------------- 2 CD4 Num 8 8 CD4 Absolute Count 3 PIDNUM Num 8 16 patient id number 1 SPECMDT Num 8 0 DATE7. Date Specimen obt. 4) STATUS.SSD01 ************ # Variable Type Len Pos Format Label ------------------------------------------------------------------------------------------ 12 AN_STEP1 Num 8 88 starting another step after step1 ? 15 AN_STEP2 Num 8 112 starting another step after step2 ? 18 D_DEATH Num 8 136 DATE7. date of death 19 D_ENDFU Num 8 144 DATE7. date of last contact 1 D_RAND1 Num 8 0 DATE7. step1: rand. date 2 D_RAND2 Num 8 8 DATE7. step2: rand. date 3 D_RAND3 Num 8 16 DATE7. step3: rand. date 4 D_START1 Num 8 24 DATE7. step1: treat. start date 6 D_START2 Num 8 40 DATE7. step2: treat. start date 8 D_START3 Num 8 56 DATE7. step3: treat. start date 10 D_STOP1 Num 8 72 DATE7. step1: date of last dose 13 D_STOP2 Num 8 96 DATE7. step2: date of last dose 16 D_STOP3 Num 8 120 DATE7. step3: date of last dose 20 ENDFUCD Num 8 152 code: reason off study 21 ENDFUTXT Char 50 160 text:reason off study 5 NVSTCD1 Num 8 32 step 1: reason never started treatment 7 NVSTCD2 Num 8 48 step 2: reason never started treatment 9 NVSTCD3 Num 8 64 step 3: reason never started treatment 26 PIDNUM Num 8 366 patient id number 24 REASTXT1 Char 70 226 text1: reason permanently off treatment 25 REASTXT2 Char 70 296 text2: reason permanently off treatment 11 STOPCD1 Num 8 80 step 1: reason stop treatment 14 STOPCD2 Num 8 104 step 2: reason stop treatment 17 STOPCD3 Num 8 128 step 3: reason stop treatment 23 TMREAS Num 8 218 code: reason permanently off treatment 22 TSDATE Num 8 210 DATE7. date permanent treatment discontinuation NVSTCD1-3 Step 1: reason never started treatment coding: 1=subject refusal 6=other STOPCD1-3 TMREAS Step 1: reason stop treatment coding: 11= completion of treatment period 12= death while on study 13= protocol-defined treatment toxicity 14= non-protocol defined toxicities or side effects 15= clinical endpoints' 16= protocol contraindicated therapy 17= patient lost to study 18= at request of patient, parent, legal guardian 19= at request of investigator or sponsor 20= miscellaneous reason defined by protocol, e.g. pregnancy and breast feeding 99= other AN_STEP1-2 Starting another step after step 1? (1=Yes, 2=No) ENDFUCD Reason for off-study code coding: 2=death 3=subject refuses further contact 4=unable to contact 6=other 5) BASEDATA.SSD01 ************** # Variable Type Len Pos Label ----------------------------------------------------------------- 8 AGE Num 8 56 Age (years) 6 AVECD4 Num 8 40 Baseline CD4 Count 4 HEMOPHIL Num 8 24 Hemophiliac? (1=yes, 0=no) 3 IVDRUG Num 8 16 IV drug history 5 KARNOF Num 8 32 Karnofsky score 9 PIDNUM Num 8 64 7 PRIORZDV Num 8 48 Months prior ZDV 2 RACETH Num 8 8 Race/ethnicity 1 SEX Num 8 0 Sex (1=male, 2=female) HEMOPHIL Hemophiliac? (1=Yes, 0=No) IVDRUG IV drug history (1=Never,2=Currently,3=Previously) KARNOF Karnofsky Performance Scale coding: 100 = Normal; no complaint; no evidence of disease 90 = Normal activity possible; minor signs/symptoms of disease 80 = Normal activity with effort; some signs/symptoms of disease' 70 = Cares for self; normal activity/active work not possible' RACETH Race/ethnicity coding: 1=White Non-Hispanic 2=Black Non-Hispanic 3=Hispanic (Regardless of Race) 4=Asian, Pacific Islander 5=American Indian, Alaskan Native 6=Other/unknown SEX Sex (1=Male, 2=Female) 6) ENDPNT2 (contains all confirmed study endpoints - AIDS or death) **************************************************************** # Variable Type Len Pos Format Label ---------------------------------------------------------------------------------- 5 AIDS_GRP Num 8 44 AIDS classification group 3 DIAG Num 8 28 diagnosis codes 4 D_ENDPNT Num 8 36 DATE7. date of endpoint 1 ENDPNT Num 8 0 type of endpoint (2=AIDS,3=death) 2 ENDTXT Char 20 8 description of endpoint 6 PIDNUM Num 8 52 patient id number ENDPNT Type of endpoint (2=AIDS,3=death) AIDS_GRP AIDS classification groupings listed in Appendix 4a coding: 0= Death 1= PCP 2= Toxoplasmosis 3= Isosporiasis 4= Cryptosporidios 5= Esoph Candidias 6= Cryptococcoses 7= Histoplasmosis 8= Coccidioidomyc 9= Mycobacterium 10= MTB 11= MAI 12= Other Atypical Mycobacterium 13= Salmonella 14= CMV 15= HSV 16= Herpes Zoster 17= PML 18= KS 19= Lymphoma of Brain 20= Non-Hodgkins Lymphoma 21= HIV Dementia 22= Wasting Syndrome 23= Other DIAG Diagnosis codes coding: 1=HIV-related death 2=non-HIV related death 3=death unknown other codes are AIDS diagnoses and are listed in Appendix 4a R_PCP Was PCP diagnosis recurrent? (1=Yes, 2=No, .=na) 7) SYMPTOM.SSD01 (grades 3 or 4) ***************************** # Variable Type Len Pos Format Label ------------------------------------------------------------------------------------ 7 GRADE Num 3 47 Grade 1 NEWSIGN Num 3 0 New/Ongoing/Resolved Sign/Symptom? 9 ONSETDT Num 5 53 DATE7. Onset Date 10 PIDNUM Num 8 58 patient id number 8 RESOLVED Num 3 50 Symptoms Resolved? 4 SPECIFY Char 30 11 Specify Symptom 3 SYMCODE Num 3 8 Symptom Code 5 SYMSITE Num 3 41 Sign/Symptom Site 6 SYMSTAT Num 3 44 Symptom Status 2 VISITDT Num 5 3 DATE7. Patient visit date SYMCODE Symptom Code from Appendix 29 coding: 715 = Lymph glands swollen/lymphadenopathy 722 = Pain with light/photosensitivity 723 = Discharge/drainage, other specify 724 = Discharge/exudate/pus 725 = Discharge - malodorous 726 = Discharge - curdy 727 = Congestion/effusion 728 = Dry 732 = Respiratory system dysfunction, specify 741 = Gastrointestinal dysfunction, specify 745 = Jaundice 754 = Discoloration/dyschromia 755 = Spasm/tremor 757 = Ache/pain/discomfort 758 = Adl/self care difficulties 759 = Contraction/cramp 760 = Edema/enlarged/swollen 761 = Blister/ulcer/lesions 762 = Rigid/tight/stiff 763 = Burning sensation 765 = Patch/plaque 766 = Reflexes, abnormal 768 = Lump/mass/nodule 776 = Erythema/redness/inflammation 777 = Weakness 778 = Numbness/paresthesia/tingling 779 = Macules/papules/rash 780 = Itchy/pruritus 781 = Bleeding/bruising/blood in.../petechiae 784 = Allergic rash/urticaria/welts/hives 785 = Dyspareunia/painful intercourse 791 = Cardiovascular dysfunction, specify 792 = Neurologic dysfunction, specify 793 = Renal/urinary system dysfunction, specify 794 = Incontinence/loss of control 797 = Genital/reproductive system abnormality, specify 798 = Mucous membrane/skin abnormality 799 = Other, specify 810 = Cachexia/wasting/weight loss 811 = Asthenia/fatigue/malaise 812 = Headache 813 = Fever 814 = Chills/rigors/sweats/nightsweats 821 = Diplopia/vision blurred/alteration 830 = Difficulty breathing/dyspnea/sob 831 = Heart rate/rhythm abnormal 833 = Breath sounds abnormal 834 = Cough 837 = Eye abnormality 838 = Ear/hearing abnormality 840 = Appetite loss/decreased/anorexia 842 = Nausea 843 = Nausea and vomiting/vomiting 845 = Hepatomegaly 846 = Splenomegaly 847 = Diarrhea/loose stools 848 = Constipation 849 = Distention/flatus/gas 850 = Dysuria/painful urination 851 = Nocturia/night urination 852 = Frequency/polyuria/increased volume 856 = Sexual drive/function alteration 865 = Taste abnormality 866 = Smell abnormality 870 = Dreams/insomnia/sleeping problems 871 = Memory loss 872 = Confusion/difficulty concentrating/cognition 873 = Agitation/hyperactive 874 = Depression 875 = Convulsion/seizure 876 = Dizzy/lightheaded/fainting 878 = Behavior changes/inappropriate behavior 883 = Menstrual dysfunction, specify 885 = Failure to thrive/development delay 886 = Level of consciousness changes/lethargy 889 = Balance/coordination abnormal 892 = Mental status changes, other specify SYMSITE Sign/Symptom Site from Appendix 28 coding: 1 = Brain/cns/intra-cranial 2 = Cerebrospinal fluid (CSF) 3 = Meninges 4 = Nerve, peripheral 5 = Retina 6 = Spinal cord 7 = Sputum 8 = Bronchial washing 9 = Alveoli/lung/pleura 10 = Bronchus 11 = Gums/mouth/teeth/tongue 13 = Stomach 14 = Intestine, small 15 = Colon/intestine, large 16 = Stool 17 = Anus/rectum/perirectal/perianal 18 = Liver 19 = Spleen 20 = Bladder/ureter/urethra/kidney 21 = Lymph nodes/glands 22 = Blood/serum/blood products 23 = Bone marrow 24 = Urine 25 = Mucous membranes/mucocutaneous/skin 26 = Genital, other 27 = Disseminated/multiple sites 28 = Chest/thorax 29 = Back/flank 30 = Abdomen/groin/pelvis 31 = Arm 32 = Finger/hand 33 = Calf/leg/thigh 34 = Foot/toe 35 = Head/scalp 36 = Neck/throat 37 = Cardiac/heart 38 = Arteries/veins/vessels 39 = Cerebrovascular 40 = Eye (not retina) 41 = Ear 42 = Larynx/pharynx/trachea/sinus/nose 43 = Penis/scrotum/testes 44 = Labia/vulva 45 = Cervix 46 = Vagina 47 = Uterus 48 = Ovary 49 = Placenta/umbilical cord 50 = Other 51 = Fetus 52 = Amniotic fluid/membrane 53 = Breast/nipple 54 = Bone (except bone marrow) 55 = Bone, upper body 56 = Bone, lower body 57 = Muscle 58 = Muscle, upper body 59 = Muscle, lower body 60 = Joint 61 = Joint, upper body 62 = Joint, lower body 63 = Fallopian tubes 64 = Musculoskeletal, other 70 = Gastrointestinal, other 71 = Respiratory, other 74 = Psychologic/emotional 75 = Neurologic, other 76 = Face/jaw/lips 77 = Extremities 78 = Esophagus/epigastric 79 = Gallbladder 80 = Emesis 81 = Pancreas 82 = Other endocrine/thyroid/pituitary 83 = Cardiovascular, other SYMSTAT Symptom Status 1 = New 2 = Ongoing 3 = History/Entry GRADE Grade coding 0 = Normal 1 = Mild 2 = Moderate 3 = Severe 4 = Life Threatening 5 = Death 8) LABTOX.SSD01 (grades 3 or 4) **************************** # Variable Type Len Pos Format Label ---------------------------------------------------------------------- 6 GRADE Num 3 55 Grade 4 LABVALUE Num 8 39 Laboratory Value 5 LIMITS Num 8 47 Upper/Lower Limits 8 PIDNUM Num 8 61 patient id number 7 RELATED Num 3 58 Related to study RX? 1 SPECDT Num 5 0 DATE7. Patient specimen date 3 SPECIFY Char 30 9 Specify Test TESTCODE Laboratory Test Code from Appendix 18 coding: ACE = Angiotensin-Converting Enzyme [U/L] ACG = Accelerator Globulin ACP = Acid Phosphatase [U/L] ACTH= AdrenoCorticoTropic Hormone [pg/mL] ADH = AntiDiuretic Hormone [pg/mL] AFP = Alpha-FetoProtein [mg/dL] AH = AntiHyaluronidase [U/mL] AHBD= Alpha-HydroxyButyric Dehydrogenase [U/mL] ALA = AminoLevulinic Acid [æg/dL] ALB = Albumin [g/dL] ALD = Aldolase [U/L] ALP = Alkaline Phosphatase [U/L] ALT = (SGPT) Serum Glutamic-Pyruvic Transaminase [U/mL] AMA = AntiMitochondrial Antibody AMS = Amylase Serum, Total [U/L] ANA = AntiNuclear Antibody ANC = Absolute Neutrophil Count [cu mm] (= WBC x % neutrophils) APTT= Activated Partial Thromboplastin Time [seconds] ASMA= Anti-Smooth Muscle Antibody ASO = Anti-Streptolysin O titer [TU] AST = (SGOT) Serum Glutamic-Oxaloacetic Transaminase [U/mL] ATL = Atypical Lymphocytes [%] ATP = Adenosine TriPhosphate [æM] BASO= Basophils [%] BSP = BromSulPhalein BUN = Blood Urea Nitrogen [mg/dL] CA = Calcium [mg/dL] CEA = CarcinoEmbryonic Antigen [ng/mL] CHOL= Cholesterol [mg/dL] CHS = Cholinesterase [U/mL] CL = Chloride [mEq/L] CO2 = Carbon diOxide [mEq/L] COHB= CarbOxyHemogloBin test [%] CORT= Cortisol CPK = Creatine PhosphoKinase [U/L] CRET= Creatinine [mg/dL] DAT = Antiglobulin Test, Direct DBIL= Direct BILirubin EOS = Eosinophils [%] ESR = Erythrocyte Sedimentation Rate [mm/hr] FBG = FiBrinoGen [æg/mL] FBS = Fasting Blood Sugar [mg/dL] FDP = Fibrin Degradation Products (Fibrin Split Products [\346g/mL] FSH = Follicle-Stimulating Hormone [mU/mL] G6PD= Glucose-6-Phosphate Dehydrogenase [U/g Hemoglobin] GGT = Gamma-Glutamyl Transferase (Gamma-Glutamyl Transpeptidase GHB = Glycosylated HemogloBin [% Total Hemoglobin] GLOB= Globulin [g/dL] GLUC= Glucose [mg/dL] (Non-Fasting) GRAN= Granulocytes (Neutrophils) [%] HBA = Hepatitis-B Surface Antigen HBD = HydroxyButyrate Dehydrogenase [U/mL] HBF = Hemoglobin, Fetal [% Total Hemoglobin] HCG = Human Chorionic Gonadotropin (Serum) [mU/mL] HCO3= BiCarbOnate [mEq/L] HCT = Hematocrit [%] HDL = High-Density Lipoprotein [mg/dL] HGB = Hemoglobin [g/dL] HI = Hemagglutination-Inhibition HLA = Human Leukocyte Antigen HPGB= Haptoglobin [mg/dL] HPL = Human Chorionic Somatomammotropin (Human Placental Lactog IAT = Antiglobulin Test, Indirect IBIL= Indirect BILirubin ID = Iditol Dehydrogenase IGA = ImmunoGlobulin A [mg/dL] IGD = ImmunoGlobulin D [mg/dL] IGE = ImmunoGlobulin E [mg/dL] IGG = ImmunoGlobulin G [mg/dL] IGM = ImmunoGlobulin M [mg/dL] K = Potassium [mEq/L] LAP = Leucine AminoPeptidase [U/L] LATS= Long-Acting Thyroid Stimulator LDH = Lactate DeHydrogenase [mU/mL] LDL = Low-Density Lipoprotein [mg/dL] LE = Lupus Erythematosus Cell Test LH = Luteinizing Hormone (Leutropin) [mU/mL] LIP = Lipase [U/L] LYM = Lymphocytes [%] MCH = Mean Corpuscular Hemoglobin [pg] MCHC= Mean Corpuscular Hemoglobin Concentration [%] MCV = Mean Corpuscular Volume [fL] MDH = Malate Dehydrogenase [U/L] MG = MaGnesium [mEq/L] MONO= Monocytes [%] MTHB= Methemoglobin [g/dL] NA = Sodium [mEq/L] NAPA= N-AcetylProcainAmide [æg/mL] NEUT= Neuttrophils (including bands) [%] NPN = Non-Protein Nitrogen [mg/dL] OCT = Ornithine CarbamoylTransferase [U/L] OF = Erythrocyte Fragility (Osmotic Fragility)[%] OTHR= Other Test, specify test and units P = Phosphorus [mg/dL] PAMS= Pancreatic Serum AMylaSe [U/L] PAP = Prostatic Acid Phosphatase [æg/L] PCO2= Partial Pressure Arterial Carbon DiOxide [mm/Hg] PG1 = PepsinoGen 1 [ng/mL] PG2 = PepsinoGen 2 [ng/mL] PH = Hydrogen ion concentration PLG = Plasminogen [units] PLT = Platelets [10^3/cu mm] PO2 = Partial Pressure Arterial Oxygen [mm/Hg] PPD = Purified Protein Derivative (tuberculin) PPG = PostPrandial Glucose [mg/dL] PSA = Prostate-Specific Antigen [ng/mL] PT = Prothrombin Time [seconds] PTH = ParaThyroid Hormone [pg/mL] PTT = Partial Thromboplastin Time [seconds] RBC = Red Blood Cells [million/æL] RETC= Reticulocyte count [%] RF = Rheumatoid Factor SACE= Serum Angiotensin-Converting Enzyme [kU/L] SO2 = Arterial Oxygen Saturation [% saturation] T3 = Triiodothyronine [ng/dL] T4 = Thyroxine [æg/dL] TBG = Thyroxine-Binding Globulin [mg/dL] TBIL= Total BILirubin [mg/dL] TBPA= Thyroxine-Binding PreAlbumin [mg/dL] TG = TriGlycerides [mg/dL] TIBC= Total Iron-Binding Capacity [æg/dL] TP = Total Protein [g/dL] TPS = TryPSin [æg/g stool] TRAN= Transferrin [mg/dL] TRP = Tubular Reabsorption Phosphate [%] TSH = Thyroid-Stimulating Hormone (Thyrotropin) [æU/mL] TSI = Thyroid-Stimulating Immunoglobulins TT = Thrombin Time [seconds] TTOS= Total TesOSterone UA = Uric Acid [mg/dL] VIS = Serum VIScosity (times that of water) VLDL= Very Low-Density Lipoprotein VMA = VanillyMandelic Acid [mg/dL] WBC = White Blood Cells [103/cu mm] ZSR = Zeta Sedimentation Rate [%] GRADE Grade coding: 0 = Normal 1 = Mild 2 = Moderate 3 = Severe 4 = Life Threatening 5 = Death RELATED Related to study RX? coding: 1 = Definitely 2 = Possibly,Probably 3 = Not Related 4 = Unable to Judge 9) _RNAP.SSD01 *********** # Variable Type Len Pos Label ---------------------------------------------------------------------- 2 COPYML Num 8 8 RNA copy numbers 3 LOGRNA Num 8 16 Log10 of RNA copy numbers 5 PIDNUM Num 8 25 patient id number 4 RANGE Char 1 24 L:below500 H:above750k N:normal 1 WEEK Num 8 0 Weeks on study The code below was used to create the .dat ascii files from the sas datasets: data _null_; file "_rnap.dat" lrecl=41; set a._rnap; put @1 pidnum @7 week @10 copyml @21 logrna @39 range ; run; data _null_; file "basedata.dat" lrecl=36; set a.basedata; put @1 pidnum @7 sex @9 raceth @11 ivdrug @13 hemophil @15 karnof @19 avecd4 @25 priorzdv @28 age ; run; data _null_; file "cd4.dat" lrecl=18; set a.cd4; put @1 pidnum @7 specmdt date7. @15 cd4 ; run; data _null_; file "endpnt2.dat" lrecl=46; set a.endpnt2; put @1 pidnum @7 endpnt @9 endtxt @30 diag @35 d_endpnt date7. @43 aids_grp ; run; data _null_; file "labtox.dat" lrecl= 69; set a.labtox; put @1 pidnum @7 specdt date7. @15 testcode @20 specify @51 labvalue @59 limits @64 grade @66 related ; run; data _null_; file "pcpid.dat" lrecl=13; set a.pcpid; put @1 pidnum @7 instn @11 reg ; run; data _null_; file "status.dat" lrecl=341; set a.status; put @1 pidnum @7 d_rand1 date7. @15 d_rand2 date7. @23 d_rand3 date7. @31 d_start1 date7. @39 nvstcd1 @47 d_start2 date7. @55 nvstcd2 @63 d_start3 date7. @71 nvstcd3 @79 d_stop1 date7. @87 stopcd1 @90 an_step1 @92 d_stop2 date7. @100 stopcd2 @103 an_step2 @106 d_stop3 date7. @114 stopcd3 @117 d_death date7. @125 d_endfu date7. @133 endfucd @136 endfutxt @187 tsdate date7. @195 tmreas @199 reastxt1 @270 reastxt2 ; run; data _null_; file "strat.dat" lrecl=9; set a.strat; put @1 pidnum @7 strat2 ; run; data _null_; file "symptom.dat" lrecl=70; set a.symptom; put @1 pidnum @7 newsign @9 visitdt date7. @17 symcode @21 specify @52 symsite @56 symstat @58 grade @60 resolved @62 onsetdt date7. ; run;