10333 05MAR96 . . 06MAR96 . . . . . 03APR96 18 2 . . . . . . 15JUL96 4 PT. STATED HE NO LONGER WANTED TO BE CONTACTED 03APR96 18 D/C FROM PROTOCOL AFTER OBTAINING RITINAVIR BY PRESCRIPTION 10350 01OCT96 . . 04OCT96 . . . . . . . . . . . . . . . . . . 10491 20FEB96 . . 20FEB96 . . . . . . . . . . . . . . . . . . 10719 15MAY96 . . 16MAY96 . . . . . 01AUG96 18 2 . . . . . . . . 01AUG96 18 PT'S KAPOSIS SARCOMA IS PROGRESSING. HE NEEDS SYSTEMIC CHEMO; HIS PRIMARY MD WISHES HIM ON OPEN-LABEL DRUGS. 11158 03JUL96 . . 03JUL96 . . . . . . . . . . . . . . . . . . 11656 04MAR96 . . 04MAR96 . . . . . . . . . . . . . . . . . . 11760 14MAR96 . . 14MAR96 . . . . . . . . . . . . . . . . . . 11767 27FEB96 . . 27FEB96 . . . . . . . . . . . . . . . . . . 11796 20MAR96 . . 21MAR96 . . . . . 09MAY96 14 2 . . . . . . 22JAN97 4 UNABLE TO CONTACT 09MAY96 14 RX TOXICITY NOT DEFINED BY PROTOCOL AS ENDPOINT GRADE II NAUSEA TO IDV 11806 28FEB96 09AUG96 . 29FEB96 . 09AUG96 . . . 09AUG96 11 1 11SEP96 14 2 . . . . . 11SEP96 14 ELEVATED VIRAL LOAD-STARTING OPEN LABEL IDV & GRADE 2 ABD PAIN POSSIBLY RELATED TO D4T 11851 17APR96 . . 18APR96 . . . . . 20OCT96 99 2 . . . . . . . . 20OCT96 99 PT HAD VIRAL LOAD PERFORMED BY PRIM MD - RESULT 542,000. PT WILL GO TO OPEN-LABEL MEDS. 11884 11MAR96 . . 11MAR96 . . . . . 25AUG96 99 2 . . . . . . . . 25AUG96 99 PATIENT'S PRIMARY M.D. HAS PERFORMED VIRAL LOAD; FOUND TO BE >110,000. HE WISHES PAITENT TO D/C FROM STUDY AND GO ON ALL OPEN-LABEL MEDS. 11898 15MAY96 18NOV96 . 16MAY96 . 21NOV96 . . . 07NOV96 11 1 . . . . . . . . . . 11899 22MAR96 . . 25MAR96 . . . . . 28AUG96 99 2 . . . . . . . . 28AUG96 99 PT'S PRIMARY M.D. PERFORMED VIRAL BURDEN; FOUND TO BE >70,000. WILL BE PLACED ON OPEN LABEL INDINAVIR AND AZT, 3TC. 11900 18MAR96 . . 18MAR96 . . . . . 04SEP96 99 2 . . . . . . . . 04SEP96 99 PT. HAD VIRAL LOAD MEASURED BY PRIMAY M.D. RESULT 240,000. PT. WILL COME OFF DRUG AND BE TREATED OPEN-LABEL MEDICATIONS. 11901 22MAR96 . . 25MAR96 . . . . . . . . . . . . . . . . . . 11902 20MAR96 07JUN96 . 21MAR96 . 11JUN96 . . . 17MAY96 11 1 . . . . . . . . . . 11904 13MAY96 . . 13MAY96 . . . . . . . . . . . . . . . . . . 11905 13MAY96 . . 13MAY96 . . . . . . . . . . . . . . . . . . 11921 22MAY96 30SEP96 . 22MAY96 . 03OCT96 . . . 02OCT96 14 1 . . . . . . . . . . 11970 18MAR96 . . 19MAR96 . . . . . . . . . . . . . . . . . . 12144 14MAR96 . . 18MAR96 . . . . . . . . . . . . . . . . . . 12283 26MAR96 . . 28MAR96 . . . . . 12APR96 14 2 . . . . . . 09SEP96 6 EXPERIENCED GRADE 3 HEADACHE;CHOSE TO DISCONTINUE 12APR96 14 PT EXPERIENCED GRADE 3 HEADACHE AND GRADE 2 FATIGUE. SHE DID NOT WANT TO CONTINUE AT DOSE REDUCTION OR RECHALLENGE WHEN APPROPRIATE. 12284 03MAY96 . . 06MAY96 . . . . . . . . . . . . . . . . . . 12286 24APR96 . . 25APR96 . . . . . 16JUL96 13 2 . . . . . . . . 16JUL96 13 ELEVATED LFT'S AND PHYSICIAN PREFERENCE. 12545 24JUL96 . . 24JUL96 . . . . . . . . . . . . . . . . . . 12566 02APR96 . 30MAY96 02APR96 . . . 01JUN96 . 31MAY96 11 1 . . . 06AUG96 19 . . . 06AUG96 19 NON WILLING/ABLE TO COME ON FOR MORE VISITS TO EVAL. SAFETY. NEEDS VISITS TO EVAL. HYDRATION STATUS & BLD C 12615 08APR96 . . 08APR96 . . . . . . . . . . . . . . . . . . 12619 02APR96 . . 02APR96 . . . . . 26NOV96 18 2 . . . . . . . . 26NOV96 18 PT & MD DECIDED TO CHANGE TO OPEN LABEL MEDS AFTER VIRAL LOAD RESULT 12620 09APR96 . . 10APR96 . . . . . 05NOV96 18 2 . . . . . . . . 05NOV96 18 PT STOPPED BLINDED IDV ON HIS OWN AND STARTED OPEN LABEL IDV NO LONGER WANTED TO BE ON BLINDED MEDICATION 12621 09APR96 . . 09APR96 . . . . . 11OCT96 18 2 . . . . . . . . 11OCT96 18 AT REQUEST OF PT DUE TO CD4 DECREASE AND FAILURE TO MAKE CLININICAL PROGRESS 12624 15MAY96 . . 15MAY96 . . . . . 09JUN96 18 2 . . . . . . . . 09JUN96 18 PT'S NON COMPLIANCE WITH VISITS 12627 14AUG96 . . 14AUG96 . . . . . 13NOV96 18 2 . . . . . . . . 13NOV96 18 AT PATIENT'S & HIS MD'S REQUEST AFTER VIRAL LOAD DONE 12631 14JUN96 . . 14JUN96 . . . . . . . . . . . . . . . . . . 12632 07AUG96 . . 07AUG96 . . . . . 04SEP96 17 2 . . . . . . 01NOV96 4 UNABLE TO CONTACT PT AFTER REPEATED ATTEMPTS 04SEP96 17 PT LOST TO FOLLOW UP 12809 07MAR96 . . 07MAR96 . . . . . 30APR96 18 2 . . . . . . . . 30APR96 18 AT THE REQUEST OF THE PATIENT MD & PATIENT TO GO ON OPEN LABEL MEDS 12832 04MAR96 . . 05MAR96 . . . . . . . . . . . . . . . . . . 12836 14FEB96 . . 14FEB96 . . . . . . . . . . . . . . . . . . 12840 18SEP96 . . 19SEP96 . . . . . . . . . . . . . . . . . . 12848 07NOV96 . . 09NOV96 . . . . . . . . . . . . . . . . . . 20116 02APR96 . . 02APR96 . . . . . . . . . . . . . . . . . . 20124 25APR96 . . 25APR96 . . . . . . . . . . . . . . . . . . 20826 29APR96 23OCT96 . 30APR96 . 11JUL96 . . . 25JUN96 13 1 . . . . . . . . . . 20977 27MAR96 . . 28MAR96 . . . . . . . . . . . . . . . . . . 21001 19APR96 . . 19APR96 . . . . . . . . . . . . . . . . . . 21003 20MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 21061 17JUL96 20NOV96 . 18JUL96 . 20NOV96 . . . 19NOV96 13 1 . . . . . . . . . . 21066 20MAR96 . . 21MAR96 . . . . . 18DEC96 18 2 . . . . . . 18DEC96 3 PT. DISTRESSED COULD NOT PROVIDE OPEN LABEL INDINA 18DEC96 18 PT. DECIDED TO STOP TREATMENT DUE TO A VIRAL LOAD OF >20,000. PT. WANTED TO BE TREATED WITH OPEN-LABEL PROTEASE INHIBITOR 21068 08JUL96 . . 08JUL96 . . . . . . . . . . . . . . . . . . 21071 02APR96 18NOV96 . 02APR96 . 01JUL96 . . . 28JUN96 13 1 . . . . . . . . . . 21072 10APR96 . . 10APR96 . . . . . . . . . . . . . . . . . . 21074 12APR96 . . 12APR96 . . . . . . . . . . . . . . . . . . 21075 21MAY96 . . 21MAY96 . . . . . . . . . . . . . . . . . . 21076 09APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 21080 10APR96 . . 11APR96 . . . . . . . . . . . . . . . . . . 21085 12APR96 . . 13APR96 . . . . . . . . . . . . . . . . . . 21086 17APR96 . . 18APR96 . . . . . 15OCT96 99 2 . . . . . . . . 15OCT96 99 PT. HAS COGNITIVE LIMITATIONS WHICH HAVE MADE HIM UNABLE TO COMPLY WITH COMPLEX MULTIDRUG REGIMEN. 21088 08MAY96 . . 10MAY96 . . . . . . . . . . . . . . . . . . 21089 14MAY96 . 30SEP96 14MAY96 . . . 30SEP96 . 30SEP96 11 1 . . . . . . . . . . 21091 21MAY96 . . 21MAY96 . . . . . . . . . . . . . . . . . . 21092 16MAY96 . . 17MAY96 . . . . . . . . . . . . . . . . . . 21097 11JUN96 . . 11JUN96 . . . . . . . . . . . . . . . . . . 21101 15JUL96 . . 15JUL96 . . . . . . . . . . . . . . . . . . 21107 28AUG96 . . 28AUG96 . . . . . . . . . . . . . . . . . . 21112 28OCT96 . . 28OCT96 . . . . . . . . . . . . . . . . . . 21113 22NOV96 . . 22NOV96 . . . . . . . . . . . . . . . . . . 30050 29APR96 . . 30APR96 . . . . . . . . . . . . . . . . . . 30270 30APR96 . . 01MAY96 . . . . . 06SEP96 12 2 . . . . . 06SEP96 06SEP96 2 PT. DIED OF MYOCARDIAL INFARCTION. 06SEP96 12 RX WERE TEMPORAILY STOPPED 9/6/96 HIGH CPK LEVELS / MI ON 9/4/96 2ND MI 9/6 PT. NOT RESUSITATED. 30522 22MAY96 . . 23MAY96 . . . . . . . . . . . . . . . . . . 30529 22MAY96 05SEP96 . 23MAY96 . 12SEP96 . . . 05SEP96 13 1 13JAN97 19 2 . . . . . 13JAN97 19 TOXICITY 30536 09OCT96 . . 10OCT96 . . . . . 08NOV96 18 2 . . . . . . 18NOV96 3 PT. WITHDREW REFUSES F/UP CARE AT THIS HOSPITAL. 08NOV96 18 PT. WITHDREW FROM STUDY. HE SAYS IT WAS "TOO MUCH" & "HE NEVER FELT BETTER. SO DID NOT WANT TO STAY ON ACTG 320 PROTOCOL. 40607 27FEB96 . . 27FEB96 . . . . . . . . . . . . . . . . . . 41271 17JAN97 . . 17JAN97 . . . . . . . . . . . . . . . . . . 41665 17APR96 . . 17APR96 . . . . . . . . . . . . . . . . . . 42369 22NOV96 . . 22NOV96 . . . . . . . . . . . . . . . . . . 42510 15MAY96 . . 15MAY96 . . . . . . . . . . . . . . . . . . 42526 21FEB96 . . 21FEB96 . . . . . 13AUG96 12 2 . . . . . 20AUG96 20AUG96 2 DEATH 13AUG96 12 DEATH 42570 16APR96 . . 16APR96 . . . . . . . . . . . . . . . . . . 42588 20FEB96 . 29MAY96 20FEB96 . . . 30MAY96 . 29MAY96 11 1 . . . . . . . . . . 43017 05MAR96 . . 05MAR96 . . . . . 15JAN97 99 2 . . . . . . . . 15JAN97 99 PRIMARY CARE PHYSICIAN AND PATIENT DECISION DUE TO LOW CD4 COUNT. 43114 14MAY96 . 21JUN96 14MAY96 . . . 24JUN96 . 23JUN96 15 1 . . . 29JUL96 12 03AUG96 03AUG96 2 DEATH 29JUL96 12 PT EXPIRED OF PNEUMONIA,CONTRIBUTING CAUSE WAS TOXOPLASMOSIS.FINAL AUTOPSY RESULTS ARE PENDING. 43121 03APR96 . . 06APR96 . . . . . 15JUL96 16 2 . . . . . . . . 15JUL96 16 DX'D MAI/MTB,STARTED TREATMENT INCLUDING RIFAMPIN(CLINICAL ENDPOINT & CONTRAINDICATED THERAPY). 43134 25APR96 . . 25APR96 . . . . . 05AUG96 18 2 . . . . . 14NOV96 14NOV96 2 EXPIRED AT HOME 05AUG96 18 PT DECIDED TO START O.L. IND 43159 06MAR96 . . 07MAR96 . . . . . 17DEC96 18 2 . . . . . . . . 17DEC96 18 PT WISHES TO GO ON OPEN LABEL INDINAVIR, SUPPORTED BY PMD. 43162 14MAR96 . . 14MAR96 . . . . . . . . . . . . . . . . . . 43171 23FEB96 . . 23FEB96 . . . . . 07OCT96 18 2 . . . . . . . . 07OCT96 18 PT AND PMD DECIDED TO GO ON OPEN LABEL IND SECONDARY TO DECREASE T CELLS & INCREASE IN VIRAL LOAD. 43173 21MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 43174 26APR96 . . 26APR96 . . . . . . . . . . . . . . . . . . 43175 05APR96 . 29MAY96 06APR96 . . . 30MAY96 . 28MAY96 11 1 . . . . . . . . . . 43181 12MAR96 . . 12MAR96 . . . . . 13MAY96 16 2 . . . . . . . . 13MAY96 16 PT DECIDED TO START OPEN - LABEL INVIRASE AS PER HIS PMD. 43185 06MAR96 . . 06MAR96 . . . . . 08NOV96 18 2 . . . . . . . . 08NOV96 18 PT'S PMD WANTS PT ON OPEN LABEL IND. 43192 04APR96 . . 04APR96 . . . . . . . . . . . . . . . . . . 43197 26APR96 . . 26APR96 . . . . . . . . . . . . . . . . . . 43198 12MAR96 15NOV96 . 12MAR96 . 20NOV96 . . . 19NOV96 13 1 . . . . . . . . . . 43201 25MAR96 . . 25MAR96 . . . . . . . . . . . . . . . . . . 43203 07MAR96 . . 07MAR96 . . . . . 19NOV96 18 2 . . . . . . . . 19NOV96 18 PATIENT REQUESTS DISCONTINUATION OF STUDY MEDICATIONS SO HE MAY GO ON OPEN-LABEL PROTEINASE INHIBITOR DUE DECREASING CD4. 43204 21MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 43206 21MAR96 . . 21MAR96 . . . . . 05SEP96 18 2 . . . . . . . . 05SEP96 18 PT STARTED ON OPEN LABEL INDINAVER 43260 04APR96 . . 04APR96 . . . . . . . . . . . . . . . . . . 43261 20JUN96 . . 20JUN96 . . . . . . . . . . . . . . . . . . 43263 26APR96 . . 26APR96 . . . . . . . . . . . . . . . . . . 43264 03MAY96 27AUG96 . 03MAY96 . 27AUG96 . . . 21AUG96 11 1 . . . . . . . . . . 43265 04JUN96 . . 04JUN96 . . . . . . . . . . . . . . . . . . 43267 26JUN96 . . 26JUN96 . . . . . . . . . . . . . . . . . . 43268 11JUN96 . . 11JUN96 . . . . . . . . . . . . . . . . . . 43269 19JUL96 . . 19JUL96 . . . . . . . . . . . . . . . . . . 43272 11JUL96 . . 11JUL96 . . . . . . . . . . . . . . . . . . 43276 28AUG96 . . 28AUG96 . . . . . . . . . . . . . . . . . . 43279 17OCT96 . . 17OCT96 . . . . . . . . . . . . . . . . . . 43280 13NOV96 . . 13NOV96 . . . . . . . . . . . . . . . . . . 43309 22JUL96 . . 22JUL96 . . . . . . . . . . . . . . . . . . 43310 29JUL96 . . 29JUL96 . . . . . . . . . . . . . . . . . . 50484 07MAR96 . . 07MAR96 . . . . . 17MAY96 14 2 . . . . . . . . 17MAY96 14 PT DEVELOPED HEPATITIS.STUDY DRUG D/C 5/17/96.GRADE IV ELEV.TRANSAMINASES.DIDN'T WANT RECHALLENGE. 50565 29APR96 . . 30APR96 . . . . . 15JUN96 14 2 . . . . . . 05AUG96 6 PT. UNWILLING TO HAVE FOLLOW-UP VISITS; TOO ILL. 15JUN96 14 PATIENT HAD MULTIPLE SIDE EFFECTS ASSOCIATED WITH INDINAVIR AT FULL AN D REDUCED DOSES ENDURING NAUSEA, VOMITING, FATIGUE. 50587 27FEB96 . . 28FEB96 . . . . . 25SEP96 14 2 . . . . . . . . 25SEP96 14 SIDE EFFECTS NOT DEFINED BY PROTOCOL BUT BY PATIENT (INTERMITTENT GR 2 NAUSEA, INTERMITTENT GR 2 VOMITING, PERSISTENT GR 2 FATIGUE). 50807 27JUN96 . . 28JUN96 . . . . . . . . . . . . . . . . . . 50881 27FEB96 . . 27FEB96 . . . . . . . . . . . . . . . . . . 50885 13MAR96 . . 15MAR96 . . . . . . . . . . . . . . . . . . 50886 15MAR96 . . 15MAR96 . . . . . . . . . . . . . . . . . . 50888 25MAR96 . . 26MAR96 . . . . . 24JUN96 18 2 . . . . . . 09SEP96 4 PATIENT LOST TO FOLLOW-UP. 24JUN96 18 PATIENT WITHDREW CONSENT 50889 20MAR96 . . 21MAR96 . . . . . 09SEP96 18 2 . . . . . . . . 09SEP96 18 PT DOC SAW INC. VIRAL LOAD, WANTS TO ASSURE PT ON PROTEASE. 50891 25MAR96 . . 25MAR96 . . . . . . . . . . . . . . . . . . 50892 09APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 50893 02APR96 . . 03APR96 . . . . . . . . . . . . . . . . . . 50894 02APR96 . . 02APR96 . . . . . 05AUG96 16 2 . . . . . . . . 05AUG96 16 INVESTIGATOR + PT'S PMD BOTH FELT OPEN LABEL INDINAVIR SHOULD BE PRESCRIBED FOR THIS PATIENT. 50896 23APR96 22AUG96 . 24APR96 . 26AUG96 . . . 12AUG96 13 1 . . . . . . . . . . 50897 25APR96 . 31MAY96 25APR96 . . . 31MAY96 . 30MAY96 11 1 . . . . . . . . . . 50898 31JUL96 27SEP96 . 02AUG96 . 30SEP96 . . . 05SEP96 13 1 . . . . . . . . . . 50899 30APR96 . . 01MAY96 . . . . . 12NOV96 19 2 . . . . . . . . 12NOV96 19 AFTER 32 WKS W/NO INCREASE IN CD4, & RISING RNA, PT SWITCHED TO REAL PROTEASE DRUG BY INVESTIGATOR 60168 22APR96 . . 23APR96 . . . . . . . . . . . . . . . . . . 60422 06MAR96 . . 07MAR96 . . . . . 11APR96 13 2 . . . . . . . . 11APR96 13 PANCREATITIS 60457 01APR96 . . 03APR96 . . . . . 10SEP96 99 2 . . . . . . . . 10SEP96 99 HIGH VIRAL LOAD 60681 14FEB96 . 21JUN96 16FEB96 . . . 25JUN96 . 24JUN96 11 1 . . . . . . . . . . 61051 14FEB96 . . 16FEB96 . . . . . . . . . . . . . . . . . . 61060 29MAY96 . 19DEC96 30MAY96 . . . 10DEC96 . 09DEC96 11 1 . . . . . . . . . . 61077 10APR96 . . 11APR96 . . . . . . . . . . . . . . . . . . 61192 14FEB96 . . 16FEB96 . . . . . . . . . . . . . . . . . . 61229 21FEB96 . . 23FEB96 . . . . . . . . . . . . . . . . . . 61230 04MAR96 . . 07MAR96 . . . . . 16MAR96 14 2 . . . . . . . . 16MAR96 14 SIDE EFFECTS DIARRHEA-GRADE 2, VOMITING-GRADE 2, NAUSEA-GRADE 2 61231 06MAR96 . 10JUN96 07MAR96 . . . 11JUN96 . 11JUN96 15 1 . . . . . . . . . . 61232 14FEB96 31JUL96 . 16FEB96 . 31JUL96 . . . 31JUL96 11 1 . . . . . . . . . . 61250 21FEB96 . 27SEP96 23FEB96 . . . 02OCT96 . 05SEP96 11 1 . . . . . . . . . . 61251 07AUG96 . . . 6 . . . . . . . . . . . . . . . . . 61252 07MAY96 25NOV96 . 08MAY96 . 03DEC96 . . . 02DEC96 11 1 . . . . . . . . . . 61257 21MAY96 . . 22MAY96 . . . . . . . . . . . . . . . . . . 61258 27MAR96 . . 28MAR96 . . . . . . . . . . . . . . . . . . 61360 13MAY96 . . 15MAY96 . . . . . . . . . . . . . . . . . . 61386 20MAR96 07OCT96 . 22MAR96 . 08OCT96 . . . 07OCT96 11 1 . . . . . . . . . . 61434 15FEB96 . . 16FEB96 . . . . . . . . . . . . . . . . . . 61435 21FEB96 . . 23FEB96 . . . . . . . . . . . . . . . . . . 61436 21FEB96 . . 23FEB96 . . . . . . . . . . . . . . . . . . 61437 20MAR96 . . 22MAR96 . . . . . 05AUG96 99 2 . . . . . . . . 05AUG96 99 HIGH VIRAL LOAD 61438 21MAR96 . . 22MAR96 . . . . . . . . . . . . . . . . . . 61439 03JUN96 . . 03JUN96 . . . . . . . . . . . . . . . . . . 61440 11JUN96 . 14JAN97 12JUN96 . . . 14JAN97 . 30DEC96 11 1 . . . . . . . . . . 61441 19JUN96 . . 20JUN96 . . . . . 24JUL96 17 2 . . . . . . 16NOV96 4 UNABLE TO CONTACT PT AFTER REPEATED ATTEMPTS 24JUL96 17 PT LOST OT FOLLOW UP 61442 25JUN96 . . 27JUN96 . . . . . 16SEP96 99 2 . . . . . . . . 16SEP96 99 HIGH VIRAL LOAD 61443 26JUN96 . . 27JUN96 . . . . . 12AUG96 18 2 . . . . . . . . 12AUG96 18 PT REQUEST 61444 19NOV96 . . 20NOV96 . . . . . . . . . . . . . . . . . . 61559 22MAR96 . . 25MAR96 . . . . . 16SEP96 18 2 . . . . . . . . 16SEP96 18 PT CHOICE - HIV RNA LEVELS GOING UP; PT. WANTS OTHER MEDS. 61560 22MAR96 . . 22MAR96 . . . . . . . . . . . . . . . . . . 61561 05APR96 . . 08APR96 . . . . . 03JUL96 99 2 . . . . . . . . 03JUL96 99 PT TRANSFERED TO SITE 0201 FORM SITE 0601, AFTER 2 VISIT DECIDED TO RE TURN TO SITE 0601 BUT NEVER KEPT SCHEDULED APPT W/ 0601 61562 26JUN96 . . 27JUN96 . . . . . 19AUG96 18 2 . . . . . . . . 19AUG96 18 HIGH VIRAL LOAD--PATIENT DECISION 61563 31JUL96 . . 01AUG96 . . . . . . . . . . . . . . . . . . 61564 17SEP96 . . 19SEP96 . . . . . . . . . . . . . . . . . . 70245 05MAR96 . . 06MAR96 . . . . . 24APR96 18 2 . . . . . . . . 24APR96 18 PT. WANTS TO GO ON OPEN LABEL INDINIVIR 70307 19MAR96 . . 19MAR96 . . . . . 26JUN96 18 2 . . . . . . 19SEP96 3 PT REFUSES TO HAVE FOLLOW-UP APPOINTMENTS 26JUN96 18 PT. NOT FEELING WELL ON MEDICATIONS AND FEELS HIS DESEASE IS PROGRESSING 70420 19MAR96 . . 20MAR96 . . . . . 15NOV96 18 2 . . . . . . 15NOV96 3 PT. GOING ON OPEN LABEL DRUG. HE LIVED IN ANOTHER 15NOV96 18 PT. DECIDED TO GO ON OPEN LABEL DRUG VIA PMD 70502 20MAR96 . . 22MAR96 . . . . . . . . . . . . . . . . . . 70503 04MAR96 . . 05MAR96 . . . . . 02OCT96 14 2 . . . . . . 17OCT96 3 PT. DECIDED HE DID NOT WANT TO COME IN TO CLINIC 02OCT96 14 PT. HAVING MULT. VAGUE SX NO FEELING WELL ON MEDS. WANTED TO FOLLOWED BY PMD, FOR POSSIBLE CHANGE OF PROTEASE INHIB. GRADE 2 MALIASE, FATIG 71683 15MAR96 . 15JUL96 18MAR96 . . 3 15MAY96 . 14MAY96 11 1 . . . . . . . . . . 71813 12MAR96 . . 13MAR96 . . . . . 03SEP96 18 2 . . . . . . . . 03SEP96 18 ELEVATED VIRAL LOAD, PATIENT TO GO ON OPEN LABEL DRUG 71881 04MAR96 . . 06MAR96 . . . . . 30AUG96 18 2 . . . . . . . . 30AUG96 18 VIRAL LOAD FOUND TO BE 500,00. PT. DECIDED HE NEEDED TO BE ON OPEN LABEL DRUG 71886 15MAR96 . . 18MAR96 . . . . . . . . . . . . . . . . . . 71887 06MAR96 . . 08MAR96 . . . . . 02OCT96 18 2 . . . . . . . . 02OCT96 18 PT. VIRAL LOAD INCREASED TO 187,000. 71890 04MAR96 . . 05MAR96 . . . . . . . . . . . . . . . . . . 71891 11MAR96 . . 12MAR96 . . . . . . . . . . . . . . . . . . 71903 05MAR96 . 28AUG96 06MAR96 . . 3 06SEP96 . 05SEP96 11 1 . . . . . . . . . . 71905 26MAR96 . . 27MAR96 . . . . . . . . . . . . . . . . . . 71906 12MAR96 15JUL96 . 13MAR96 . 15MAY96 . . . 13MAY96 11 1 . . . . . . . . . . 71908 13MAR96 . 15JUL96 15MAR96 . . . 10MAY96 . 09MAY96 11 1 . . . 03SEP96 17 . 03SEP96 4 PT. LOST TO FOLLOW-UP PROBABLY DUE TO PSYCHIATRIC 03SEP96 17 PT. HAS BEEN LOST TO FOLLOW-UP. HE HAS UNDIAGNOSED SEVER PSHYCIATRIC PROBLEM. UNABLE TO REACH BY PHONE. PT. RETURND MEDS TO CLINIC. 71910 19MAR96 . . 20MAR96 . . . . . . . . . . . . . . . . . . 71912 14MAR96 . . 15MAR96 . . . . . 15AUG96 18 2 . . . . . . 03OCT96 3 PT. REFUSED ANY FOLLOW-UP. CURRENTLY ON INDINIVIR 15AUG96 18 PT. PMD WANTED TO SWITCH TO OPEN LABEL INDINIVIR DUE TO INCREASE IN VI RAL LOAD. 71913 26MAR96 . . 27MAR96 . . . . . . . . . . . . . . . . . . 71916 12APR96 . . 15APR96 . . . . . . . . . . . . . . . . . . 71917 19MAR96 15JUL96 . 20MAR96 . 08MAY96 . . . 06MAY96 11 1 05SEP96 18 2 . . . 05SEP96 4 PT WENT ON OPEN LABEL. UNABLE TO CONTACT AFTER REP 05SEP96 18 PT. WENT ON OPEN LAEL DRUG IN OCTOBER. PT. MISSED EOS VISIT AND WILL NOT RETURN PHONE CALLS. 71921 20MAR96 . . 22MAR96 . . . . . . . . . . . . . . . . . . 71922 26MAR96 . . 27MAR96 . . . . . 15OCT96 18 2 . . . . . . 14NOV96 3 PT. REFUSES FOLLOW-UP CONTACT 15OCT96 18 PT.'S PMD WANTED PT. TO START OPEN LABEL PROTOCOL DUE TO VIRAL LOAD OF 700,000. 71927 29APR96 . . 01MAY96 . . . . . . . . . . . . . . . . . . 71928 12APR96 . . 15APR96 . . . . . . . . . . . . . . . . . . 71935 12APR96 . . 16APR96 . . . . . . . . . . . . . . . . . . 71939 01MAY96 . . 03MAY96 . . . . . . . . . . . . . . . . . . 71950 24JUN96 . . 27JUN96 . . . . . . . . . . . . . . . . . . 71952 18JUL96 . . 19JUL96 . . . . . . . . . . . . . . . . . . 90152 17SEP96 . . 17SEP96 . . . . . . . . . . . . . . . . . . 90154 09APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 90189 31JAN96 . . 31JAN96 . . . . . . . . . . . . . . . . . . 90328 13FEB96 . . 13FEB96 . . . . . . . . . . . . . . . . . . 90592 26FEB96 . . 26FEB96 . . . . . 08OCT96 18 2 . . . . . . . . 08OCT96 18 PT SEL-WITHDREW FOLLOWING ADVICE OF PMD WHO CHANGED PT'S THERAPY. 90600 02OCT96 . . 02OCT96 . . . . . . . . . . . . . . . . . . 90683 06MAR96 . 16SEP96 06MAR96 . . . 16SEP96 . 16SEP96 11 1 . . . . . . . . . . 90703 28FEB96 . . 28FEB96 . . . . . 21NOV96 99 2 . . . . . . . . 21NOV96 99 PER PMD 90779 21FEB96 12SEP96 . 21FEB96 . 12SEP96 . . . 11SEP96 11 1 . . . . . . . . . . 90839 24JUL96 . . 24JUL96 . . . . . . . . . . . . . . . . . . 90855 28MAR96 . . 28MAR96 . . . . . . . . . . . . . . . . . . 90861 04MAR96 . . 04MAR96 . . . . . 07AUG96 18 2 . . . . . . . . 07AUG96 18 PT SELF WITHDREW,DECIDED HE WOULD PREFER TO HAVE HIS PMD GIVE HIM OPEN LABEL MEDICATIONS. 90913 29JAN96 . . 29JAN96 . . . . . . . . . . . . . . . . . . 90915 29JAN96 . . 29JAN96 . . . . . . . . . . . . . . . . . . 90916 31JAN96 . . 31JAN96 . . . . . 27AUG96 16 2 . . . . . 13NOV96 13NOV96 2 PATIENT EXPIRED 27AUG96 16 PT DIAGNOSED W/M.KANSASII FOR THE SECOND TIME.MD TREATED/STARTED ON OPEN-LABEL 3TC/ZDV. 90917 31JAN96 . . 31JAN96 . . . . . . . . . . . . . . . . . . 90918 09FEB96 . 26MAR96 09FEB96 . . . 26MAR96 . 21FEB96 11 1 . . . . . . . . . . 90920 15FEB96 . . 15FEB96 . . . . . . . . . . . . . . . . . . 90921 21FEB96 . . 21FEB96 . . . . . . . . . . . . . . . . . . 90922 27FEB96 . . 27FEB96 . . . . . . . . . . . . . . . . . . 90923 27FEB96 . . 27FEB96 . . . . . 21APR96 18 2 . . . . . 05MAY96 05MAY96 2 PATIENT DIED 5-5-96 21APR96 18 PT SELF-WITHDRAWAL OF STUDY MEDS WHILE HOSPITALIZED,CHOSE NOT TO TAKE ANY FURTHER STUDY MEDS. 90924 28FEB96 . . 28FEB96 . . . . . . . . . . . . . . . . . . 90927 14MAR96 . . 14MAR96 . . . . . . . . . . . . . . . . . . 90929 28MAR96 . . 28MAR96 . . . . . . . . . . . . . . . . . . 90932 11APR96 . . 11APR96 . . . . . 23OCT96 13 2 . . . . . . . . 23OCT96 13 REPEAT GR III LFT'S AFTER DOSE LEVEL ONE REDUCTION. 90940 25JUN96 . . 25JUN96 . . . . . . . . . . . . . . . . . . 90941 27JUN96 . . 27JUN96 . . . . . . . . . . . . . . . . . . 90942 09JUL96 . . 09JUL96 . . . . . . . . . . . . . . . . . . 90943 10JUL96 . . 10JUL96 . . . . . . . . . . . . . . . . . . 90944 30JUL96 . . 30JUL96 . . . . . . . . . . . . . . . . . . 90952 01AUG96 . . 01AUG96 . . . . . . . . . . . . . . . . . . 90953 13AUG96 . . 13AUG96 . . . . . . . . . . . . . . . . . . 90954 27AUG96 . . 27AUG96 . . . . . . . . . . . . . . . . . . 90955 03SEP96 . . 03SEP96 . . . . . . . . . . . . . . . . . . 90956 09SEP96 . . 09SEP96 . . . . . . . . . . . . . . . . . . 90958 14OCT96 . . 14OCT96 . . . . . . . . . . . . . . . . . . 90961 26NOV96 . . 27NOV96 . . . . . . . . . . . . . . . . . . 90962 11DEC96 . . 12DEC96 . . . . . . . . . . . . . . . . . . 90964 12DEC96 . . 12DEC96 . . . . . . . . . . . . . . . . . . 90965 12DEC96 . . 13DEC96 . . . . . . . . . . . . . . . . . . 90966 16DEC96 . . 17DEC96 . . . . . . . . . . . . . . . . . . 11012009APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 11025722NOV96 . . 22NOV96 . . . . . . . . . . . . . . . . . . 11033322APR96 . 19JUN96 22APR96 . . 6 19JUN96 . 19JUN96 11 1 . . . 27SEP96 14 . . . 27SEP96 14 DEVELOPED GR 3 RASH 1 WK AFTER RESUMING OPEN LABEL INDINAVIR & DOES NO T WISH TO RECHALLANGE 11062016FEB96 . . 19FEB96 . . . . . . . . . . . . . . . . . . 11069816FEB96 . . 19FEB96 . . . . . 14NOV96 16 2 . . . . . . . . 14NOV96 16 PT'S MD WISHED TO START OPEN LABEL PRO- TEASE INHIBITOR D/T VIRAL LOAD LEVELS 11074419APR96 . . 16MAY96 . . . . . 01AUG96 14 2 . . . . . . . . 01AUG96 14 HAD VAGUE C/O GR 2 DIZZINESS AND "FEELS BETTER" OFF STUDY DRUG 11075026FEB96 . . 26FEB96 . . . . . . . . . . . . . . . . . . 11079220MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 11081403JUN96 . . 05JUN96 . . . . . 16JAN97 13 2 . . . . . . . . 16JAN97 13 GGR 3 NAUSEA-LEVEL 1 REDUCT. IDV DONE BUT PT INTOLERANT IDV. NAUSEA IMPROVED BUT NOT COMPLETELY 11103206JUN96 . . 06JUN96 . . . . . 13JAN97 16 2 . . . . . . . . 13JAN97 16 CLINIC PROVIDER WISHED TO CHG ANTIRETROVIRALS D/T INCREASING VIRAL LOA DS 11108721MAY96 . . 22MAY96 . . . . . . . . . . . . . . . . . . 11110010APR96 . . 12APR96 . . . . . . . . . . . . . . . . . . 11118120MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 11120227MAR96 . . 28MAR96 . . . . . 02OCT96 18 2 . . . . . . . . 02OCT96 18 PT REQUESTS STOPPING STUDY MEDS AND DOES NOT MEET OPEN LABEL REQUIREMENTS PER PROTOCOL. 11120512MAR96 . . 14MAR96 . . . . . . . . . . . . . . . . . . 11129601MAR96 . . 07MAR96 . . . . . 28MAR96 18 2 . . . . . . 28MAR96 6 PT CHOICE;UNWILLING TO GO TO MAIN UNIT 28MAR96 18 PT CHOICE;SUBUNIT CLOSING;PT DOES NOT WISH TO TRANSFER TO MAIN UNIT 11129701MAR96 . . 04MAR96 . . . . . 12APR96 18 2 . . . . . . 29APR96 6 SUB-UNIT CLOSING 12APR96 18 Pt wanted prescription drug 11129804MAR96 . . . 1 . . . . . . . . . . . . . 04MAR96 3 REFUSES CONTACT . . 11129904MAR96 . . . 1 . . . . . . . . . . . . . 28MAY96 6 SUB-UNIT CLOSING. . . 11130005MAR96 . . . 1 . . . . . . . . . . . . . 05MAR96 3 REFUSES FURTHER CONTACT . . 11130104MAR96 . . . 1 . . . . . . . . . . . . . 05MAR96 3 REFUSES FURTHER CONTACT . . 11130205MAR96 . . . 1 . . . . . . . . . . . . . 28MAY96 6 SUB-UNIT CLOSING, DOES NOT WISH TO GO TO ROCHESTER . . 11132908FEB96 . . 09FEB96 . . . . . 11SEP96 18 2 . . . . . . . . 11SEP96 18 STOPPING STUDY DRUG TO PERSUE OTHER ANTIRETROVIRALS OPTIONS 11133909FEB96 18NOV96 . 09FEB96 . 18NOV96 . . . 18NOV96 11 1 23DEC96 16 2 . . . . . 23DEC96 16 PMD WISHES TO BEGIN OPEN LABEL INDINAVIR 11134016FEB96 . . 15FEB96 . . . . . . . . . . . . . . . . . . 11134125MAR96 . . 25MAR96 . . . . . 07JAN97 18 2 . . . . . . . . 07JAN97 18 PT DECISION - CONCERNED RE: INCREASING VIRAL LOAD & WISHED TO BE CERTAIN SHE WAS ON PROTEASE INHIB. 11134219FEB96 . . 19FEB96 . . . . . 30APR96 18 2 . . . . . . . . 30APR96 18 PATIENT REQUESTS PERMANENT STUDY DRUG TERMINATION ON ADVICE FROM PERSON PHYSICIAN 11134628FEB96 . . 28FEB96 . . . . . . . . . . . . . . . . . . 11134722APR96 . . 23APR96 . . . . . . . . . . . . . . . . . . 11134814MAR96 . . 14MAR96 . . . . . 09MAY96 18 2 . . . . . 14NOV96 14NOV96 2 DEATH 09MAY96 18 PT STATES "TOO MANY PILLS TO TAKE". WANTS TO HAVE "LESS STRESS" IN LIFE. 11134904MAR96 . . 05MAR96 . . . . . 13MAY96 18 2 . . . . . . . . 13MAY96 18 NO LONGER WISHES TO PARTICPATE-WANTS OPEN LABEL DRUG 11135318MAR96 . . 18MAR96 . . . . . . . . . . . . . . . . . . 11135515APR96 08JUL96 . 15APR96 . 08JUL96 . . . 08JUL96 11 1 06NOV96 99 2 . . . . . 06NOV96 99 PATIENT'S PMD WISHES TO START OPEN LABEL INDINAVIR DUE TO HIGH VIRAL L OADS 11135624APR96 . . 25APR96 . . . . . . . . . . . . . . . . . . 11135730APR96 09AUG96 . 01MAY96 . 12AUG96 . . . 06AUG96 11 1 . . . . . . . . . . 11136325SEP96 . . 25SEP96 . . . . . . . . . . . . . . . . . . 11141311APR96 02JAN97 . 11APR96 . 07JAN97 . . . 02JAN97 13 1 . . . . . . . . . . 11145929OCT96 . . 30OCT96 . . . . . 30OCT96 18 2 . . . . . . 30OCT96 6 PHONE CONTACT MADE REPEATEDLY. NO CLINIC VISITS. 30OCT96 18 NON-COMPLIANCE-CONTINUES TO MISS SCHEDULED APPTS. HAVE NOT SEEN SINCE ENTRY VISIT! (10-30-96) 12077513MAR96 . . 13MAR96 . . . . . . . . . . . . . . . . . . 12089715FEB96 . . 16FEB96 . . . . . . . . . . . . . . . . . . 12101426FEB96 . . 26FEB96 . . . . . 18SEP96 18 2 . . . . . . . . 18SEP96 18 PT WANTED TO GO ON OPEN LABEL INDINAVIR DUE TO HIGH VIRAL LOAD. 12108811MAR96 . . 11MAR96 . . . . . 18JUN96 18 2 . . . . . . 19JUN96 3 PATIENT REFUSES FURTHER PARTICIPATION. 18JUN96 18 PT REQUESTED TO GO OFF STUDY SO HE COULD GO ON OPEN-LABEL INDINAVIR. 12113108FEB96 . . 08FEB96 . . . . . . . . . . . . . . . . . . 12114004MAR96 . . 04MAR96 . . . . . . . . . . . . . . . . . . 12114312FEB96 . 16APR96 12FEB96 . . . 16APR96 . 01APR96 15 1 . . . . . . . . . . 12114904MAR96 . 24APR96 04MAR96 . . . 29APR96 . 29APR96 11 1 . . . . . . . . . . 12119004MAR96 07JUN96 . 04MAR96 . 10JUN96 . . . 10JUN96 11 1 . . . . . . . . . . 12121113FEB96 . . 13FEB96 . . . . . . . . . . . . . . . . . . 12121213FEB96 . . 13FEB96 . . . . . . . . . . . . . . . . . . 12121620FEB96 . 24APR96 20FEB96 . . . 26APR96 . 26APR96 11 1 . . . . . . . . . . 12121727FEB96 . 08JUL96 27FEB96 . . . 09JUL96 . 09JUL96 11 1 . . . . . . . . . . 12121820FEB96 13MAY96 . 21FEB96 . 14MAY96 . . . 14MAY96 11 1 03OCT96 18 2 . . . . . 03OCT96 18 PT WANTED TO GO OFF STUDY TO OBTAIN OPEN LABEL PROTEASE INHIBITOR DUE TO VIRAL LOAD GREATER THAN 1 MILLION 12121922FEB96 . 25JUN96 22FEB96 . . . 25JUN96 . 26JUN96 15 1 . . . . . . . . . . 12122011MAR96 . . 12MAR96 . . . . . 15MAY96 18 2 . . . . . . . . 15MAY96 18 NON-COMPLIANCE. PT DID NOT WANT TO TAKE SO MANY PILLS.PT ADMITS TO BEING NON-COM WITH STDY MEDS.RETURN TO MUCH 12122111MAR96 . . 11MAR96 . . . . . 24OCT96 18 2 . . . . . . 24OCT96 3 PATIENT REFUSES FURTHER PARTICIPATION IN RESEARCH 24OCT96 18 PATIENT WITHDREW CONSENT AND REFUSED FURTHER PARTICIPATION 12122214MAR96 . . 14MAR96 . . . . . 15MAR96 18 2 . . . . . . 07MAY96 3 PT REFUSES FURTHER FOLLOW-UP PT WITHDREW FROM STDY 15MAR96 18 PT WAS NONCOMPLIANT WITH STUDY MEDS AND PATIENT VISITS.PT SAID HE WANTED TO WITHDRAWN FROM STUDY AND FURTHER-U 12122320MAR96 . . 20MAR96 . . . . . . . . . . . . . . . . . . 12122420MAR96 . . 20MAR96 . . . . . . . . . . . . . . . . . . 12122918APR96 . 18OCT96 18APR96 . . . 18OCT96 . 18OCT96 15 1 . . . . . . . . . . 12123606MAY96 . . 06MAY96 . . . . . 30DEC96 18 2 . . . . . . . . 30DEC96 18 PATIENT AND PRIMARY CARE PROVIDER REQUESTED THAT PT DICONTINUE FROM STUDY 12123709MAY96 . . 09MAY96 . . . . . 24OCT96 18 2 . . . . . . 23DEC96 3 PATIENT WITHDRAWLS CONSENT AND REFUSES FURTER PART 24OCT96 18 PATIENT REQUEST BASED ON HIGH VIRAL LOAD. HE WANTS TO HAVE MORE CONTRO OVER HIS ANTIRETROVIRAL REGIMEN. 12123813MAY96 . 25JUN96 13MAY96 . . . 09JUL96 . 09JUL96 11 1 . . . . . . . . . . 14100021MAY96 . . 21MAY96 . . . . . . . . . . . . . . . . . . 14107422MAR96 . . 22MAR96 . . . . . 04JUL96 18 2 . . . . . . . . 04JUL96 18 PATIENT WANTS OPEN LABE INDINAVIR 14107711APR96 . . 13APR96 . . . . . . . . . . . . . . . . . . 14108517APR96 12SEP96 . 17APR96 . 13JUN96 . . . 13JUN96 11 1 05AUG96 18 2 . . . . . 05AUG96 18 BOTH PATIENT AND PMD WANTED OPEN LABEL ROX OF INDINAVIR 14108605APR96 . . 05APR96 . . . . . . . . . . . . . . . . . . 14108912APR96 23OCT96 . 12APR96 . 23OCT96 . . . 23OCT96 19 1 27NOV96 18 2 . . . . . 27NOV96 18 PATIENT DECISION BECAUSE HE WANTS OPEN LABEL PROTEASE INHIBITOR 14109118APR96 . . 18APR96 . . . . . 19JUN96 13 2 . . . . . . . . 19JUN96 13 PATIENT DEVELOPED PANCREATITIS 14109223APR96 . . 23APR96 . . . . . 19NOV96 99 2 . . . . . . . . 19NOV96 99 AT THE REQUEST OF PATIENTS PMD, BECAUSE VIRAL LOAD IS 90,000 14110825SEP96 . . 25SEP96 . . . . . . . . . . . . . . . . . . 15005320MAR96 . . 20MAR96 . . . . . . . . . . . . . . . . . . 15012826MAR96 . . 26MAR96 . . . . . . . . . . . . . . . . . . 15014731MAY96 . . 31MAY96 . . . . . . . . . . . . . . . . . . 15027226MAR96 . . 26MAR96 . . . . . . . . . . . . . . . . . . 15045625JUN96 . . 25JUN96 . . . . . 09OCT96 14 2 . . . . . . . . 09OCT96 14 GRADE 3 FATIGUE; UNWILLING TO TRY REDUCED DOSE PER PROTOCOL OR SEQUENT REINTRODUCTION- TEAM REFUSED REQUEST TO TRY D4T/3TC/REDUCED IDV 15046806MAR96 . . 06MAR96 . . . . . 27AUG96 18 2 . . . . . . . . 27AUG96 18 PT HAD VIRAL LOAD DONE AT LOCAL MD & IT WAS OVER 1 MILLION. HE & HIS M.D. DECIDED IT WAS IN HIS BEST INTERESTE TO BE ON OPEN LABEL CRIXIVAN 15050309APR96 . . 09APR96 . . . . . 22OCT96 16 2 . . . . . . . . 22OCT96 16 PRIMARY PHYSICIAN WANTS PATIENT ON OPEN LABEL IDV FOR VIRAL LOAD >120,000 COPIES/ML 15051602APR96 . . 02APR96 . . . . . . . . . . . . . . . . . . 15052930APR96 . . 30APR96 . . . . . . . . . . . . . . . . . . 15055501MAY96 . . 01MAY96 . . . . . 25JUN96 18 2 . . . . . . . . 25JUN96 18 STUDY MED DEMANDS I.E. PILL CERENT, EATING/TIMING RESTRICTIONS HINDER QDL 15058205MAR96 . . 06MAR96 . . . . . . . . . . . . . . . . . . 15059507MAY96 . . 07MAY96 . . . . . . . . . . . . . . . . . . 15060611JUN96 . . 11JUN96 . . . . . . . . . . . . . . . . . . 15061405MAR96 . . 05MAR96 . . . . . . . . . . . . . . . . . . 15061716MAY96 . . 17MAY96 . . . . . . . . . . . . . . . . . . 15062402APR96 . . 02APR96 . . . . . 11APR96 12 2 . . . . . 22APR96 22APR96 2 DEATH 11APR96 12 DEATH WHILE ON STUDY 15063227FEB96 . . 27FEB96 . . . . . . . . . . . . . . . . . . 15063321MAR96 . . 21MAR96 . . . . . 08APR96 14 2 . . . . . . . . 08APR96 14 PATIENT DEVELOPED GRADE 2 PERSISTANT NAUSEA AND WAS UNWILLING TO CONTINUE ON THE STUDY. 15063526MAR96 . . 26MAR96 . . . . . . . . . . . . . . . . . . 15063604APR96 14JUN96 . 04APR96 . 17JUN96 . . . 16JUN96 11 1 . . . . . . . . . . 15063704APR96 . . 04APR96 . . . . . . . . . . . . . . . . . . 15063810MAY96 . . 10MAY96 . . . . . . . . . . . . . . . . . . 15064319SEP96 22OCT96 . 19SEP96 . 22OCT96 . . . 17OCT96 13 1 . . . . . . . . . . 15070907MAY96 . . 07MAY96 . . . . . . . . . . . . . . . . . . 15071706MAY96 . . 06MAY96 . . . . . . . . . . . . . . . . . . 15071810JUN96 . . 11JUN96 . . . . . 18NOV96 13 2 . . . . . . . . 18NOV96 13 TREATMENT TOXICITY AS DEFINED BY PROTOCOL 15071921MAY96 . . 22MAY96 . . . . . . . . . . . . . . . . . . 15076125APR96 . . 25APR96 . . . . . . . . . . . . . . . . . . 15079009APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 15079102MAY96 . . 02MAY96 . . . . . . . . . . . . . . . . . . 15079309APR96 . . 10APR96 . . . . . . . . . . . . . . . . . . 15079516MAY96 . . 16MAY96 . . . . . 11AUG96 18 2 . . . . . . 31DEC96 3 PT REFUSES ALL FURTHER CONTACT 11AUG96 18 PT DID NOT WANT TO BE OFF STUDY DRUG BECAUSE OF ELEVATED LIVER ENZYMES AND DID NOT WANT TO BE ON BLINDED PROTEASE INHIBITOR. 15079708OCT96 . . 08OCT96 . . . . . . . . . . . . . . . . . . 15083706MAY96 . 14NOV96 06MAY96 . . . 14NOV96 . 14NOV96 11 1 . . . . . . . . . . 15084703MAY96 . . 03MAY96 . . . . . . . . . . . . . . . . . . 15085328MAY96 . . 28MAY96 . . . . . . . . . . . . . . . . . . 15086028MAR96 . . 28MAR96 . . . . . . . . . . . . . . . . . . 15086309MAY96 . . 09MAY96 . . . . . 08NOV96 18 2 . . . . . . . . 08NOV96 18 PT STOPPED DRUGS TO GO ON PROTEASE INHIBITOR DUE TO HIGH VIRAL LOAD. 15087701APR96 . . 01APR96 . . . . . 17OCT96 18 2 . . . . . . 17OCT96 3 PT REFUSES TO KEEP STUDY VISITS & REFUSES PHONE CA 17OCT96 18 PT LAST SEEN 6/96, REFUSES TO SCHEDULE VISITS OR ACCEPT PHONE CALLS. 15089728MAR96 23JUL96 . 28MAR96 . 23JUL96 . . . 15JUL96 11 1 06JAN97 18 2 . . . . . 06JAN97 18 PT WISHES TO CHANGE MEDICATION DUE TO HIGH VIRAL LOAD. 15090106JUN96 . . 06JUN96 . . . . . . . . . . . . . . . . . . 15090308APR96 . . 08APR96 . . . . . . . . . . . . . . . . . . 15090522APR96 . . 22APR96 . . . . . . . . . . . . . . . . . . 15090622APR96 19JUN96 . 24APR96 . 19JUN96 . . . 21MAY96 11 1 . . . . . . . . . . 15090717APR96 . . 18APR96 . . . . . . . . . . . . . . . . . . 15090809MAY96 . . 09MAY96 . . . . . . . . . . . . . . . . . . 15093525JUN96 . . 26JUN96 . . . . . 08DEC96 99 2 . . . . . . . . 08DEC96 99 PT HAD AN HIV-RNA 7/24/96 THAT WAS 129,517 COPIES. THIS WAS REPEATED 10/16/96 & INCR TO 192,857. PT & PRIM MD FEEL HE SHOULD BE ON PROT INH 15094724JUL96 . . 25JUL96 . . . . . 11SEP96 12 2 . . . . . 12SEP96 12SEP96 2 DEATH 11SEP96 12 DEATH 15095521JUN96 . . 24JUN96 . . . . . . . . . . . . . . . . . . 15095727JUN96 05NOV96 . 27JUN96 . 06NOV96 . . . 05NOV96 13 1 . . . . . . . . . . 15095810JUL96 . . 10JUL96 . . . . . . . . . . . . . . . . . . 15095915JUL96 24SEP96 . 15JUL96 . 25SEP96 . . . 24SEP96 13 1 . . . . . . . . . . 15096124OCT96 . . 24OCT96 . . . . . . . . . . . . . . . . . . 15096319NOV96 . . 20NOV96 . . . . . . . . . . . . . . . . . . 15096509DEC96 . . 09DEC96 . . . . . . . . . . . . . . . . . . 15100911APR96 . . 11APR96 . . . . . . . . . . . . . . . . . . 15101009MAY96 . . 09MAY96 . . . . . . . . . . . . . . . . . . 15101306JUN96 . . 06JUN96 . . . . . . . . . . . . . . . . . . 15101408AUG96 . . 08AUG96 . . . . . . . . . . . . . . . . . . 15101611SEP96 . . 11SEP96 . . . . . . . . . . . . . . . . . . 16025010JUN96 . . 10JUN96 . . . . . 26DEC96 99 2 . . . . . . . . 26DEC96 99 DECREASED CD4 COUNT SECONDARY TO LACK OF CLINICAL PROGRESS SINCE INITIATION OF ACTG 320 PROTOCOL 16027115OCT96 . . 15OCT96 . . . . . . . . . . . . . . . . . . 16100919APR96 . . 19APR96 . . . . . 20NOV96 18 2 . . . . . . . . 20NOV96 18 PT REQ AFTER DISC W PRIMARY MD, PT FELT HE WAS NOT MAKING PROGRESS CLINICALLY WHILE ON STUDY 16101018APR96 04NOV96 . 19APR96 . 05NOV96 . . . 25OCT96 11 1 . . . . . . . . . . 16101118APR96 18SEP96 . 19APR96 . 20SEP96 . . . 04SEP96 11 1 07JAN97 19 2 . . . . . 07JAN97 19 PATIENT HAS DECLINING CD4 COUNT AND HIGH VIRAL LOAD 16101218APR96 . 16SEP96 19APR96 . . . 16SEP96 . 16SEP96 11 1 . . . . . . . . . . 16101329APR96 . . 29APR96 . . . . . . . . . . . . . . . . . . 16101414MAY96 . . 14MAY96 . . . . . . . . . . . . . . . . . . 16101515MAY96 . . 15MAY96 . . . . . 16MAY96 18 2 . . . . . . . . 16MAY96 18 PT ASKED TO WITHDRAW FROM STUDY DUE TO DIFFICULTY IN SWALLOWING THE INDINAVIR/PLACEBO CAPSULES IT DIFFIC 16101620MAY96 . . 20MAY96 . . . . . . . . . . . . . . . . . . 16101730MAY96 . . 30MAY96 . . . . . 22JAN97 18 2 . . . . . . . . 22JAN97 18 PT HAS NOT HAD AN INCREASE IN CD4 COUNT SINCE BASELINES; DESIRES THREE DRUG THERAPY 16101831MAY96 . . 31MAY96 . . . . . . . . . . . . . . . . . . 16101904JUN96 . . 04JUN96 . . . . . . . . . . . . . . . . . . 16102007JUN96 . . 07JUN96 . . . . . . . . . . . . . . . . . . 16102110JUN96 . . 10JUN96 . . . . . . . . . . . . . . . . . . 16102211JUN96 . . 11JUN96 . . . . . . . . . . . . . . . . . . 16102311JUN96 . . 12JUN96 . . . . . 09JAN97 18 2 . . . . . . . . 09JAN97 18 PT WITHDRAWING FROM STUDY BECAUSE HE IS MOVING TO ANOTHER STATE,HE DOES NOT WISH TO BE TRANSFERRED 16102424JUN96 . . 24JUN96 . . . . . . . . . . . . . . . . . . 16102525JUN96 . . 28JUN96 . . . . . . . . . . . . . . . . . . 16102626JUN96 . . 26JUN96 . . . . . . . . . . . . . . . . . . 16102726JUN96 . . 26JUN96 . . . . . . . . . . . . . . . . . . 16102827JUN96 20SEP96 . 27JUN96 . 25SEP96 . . . 16SEP96 13 1 . . . . . . . . . . 16102923JUL96 . . 24JUL96 . . . . . 16SEP96 14 2 . . . . . . . . 16SEP96 14 PT REQ D/C FROM STUDY BECAUSE HE STATES INTOL TO MEDS AND REFUSES TO RETRY, WANTS TO CONT AZT/3TC 16103025JUL96 13NOV96 . 25JUL96 . 13NOV96 . . . 13NOV96 11 1 . . . . . . . . . . 16103126JUL96 . . 26JUL96 . . . . . . . . . . . . . . . . . . 16103216SEP96 06DEC96 . 16SEP96 . 17DEC96 . . . 05DEC96 11 1 . . . . . . . . . . 16103325SEP96 . . 25SEP96 . . . . . . . . . . . . . . . . . . 16103409OCT96 . . 10OCT96 . . . . . . . . . . . . . . . . . . 16103521OCT96 . . 21OCT96 . . . . . . . . . . . . . . . . . . 16103620DEC96 . . 20DEC96 . . . . . . . . . . . . . . . . . . 16103702JAN97 . . 02JAN97 . . . . . . . . . . . . . . . . . . 16103810JAN97 . . 13JAN97 . . . . . . . . . . . . . . . . . . 17028308JUL96 . . 08JUL96 . . . . . 10SEP96 13 2 . . . . . . . . 10SEP96 13 REMOVED FROM STUDY TREATMENT DUE TO HEPATOTOXICITY PER PROTOCOL CHAIR 17039524JUL96 . . 24JUL96 . . . . . . . . . . . . . . . . . . 17054425JUN96 . . 25JUN96 . . . . . 25NOV96 99 2 . . . . . . . . 25NOV96 99 PT'S PRIMARY MD DECISION DUE TO ELEVATED VIRAL LOAD 17062730MAY96 . . 30MAY96 . . . . . . . . . . . . . . . . . . 17063921AUG96 . . 21AUG96 . . . . . . . . . . . . . . . . . . 17083916APR96 . . 16APR96 . . . . . 17MAY96 14 2 . . . . . . . . 17MAY96 14 GRADE II NAUSEA 17200914JUN96 . . 14JUN96 . . . . . 20NOV96 99 2 . . . . . . . . 20NOV96 99 PT'S PRIMARY MD REQUESTING PT CAME OFF STUDY DRUG DUE TO ELAVATED VIRAL LOAD 17201010JUN96 . . 10JUN96 . . . . . . . . . . . . . . . . . . 17201129MAY96 12DEC96 . 29MAY96 . 12DEC96 . . . 14NOV96 11 1 . . . . . . . . . . 17201228MAY96 . . 28MAY96 . . . . . . . . . . . . . . . . . . 17201318JUN96 . . 18JUN96 . . . . . . . . . . . . . . . . . . 17201417JUN96 . . 17JUN96 . . . . . . . . . . . . . . . . . . 17201519JUN96 . . 19JUN96 . . . . . . . . . . . . . . . . . . 17201618JUN96 . . 18JUN96 . . . . . . . . . . . . . . . . . . 17201709JUL96 . . 09JUL96 . . . . . . . . . . . . . . . . . . 17202029JUL96 . . 29JUL96 . . . . . . . . . . . . . . . . . . 17202215AUG96 . . 15AUG96 . . . . . . . . . . . . . . . . . . 17203311SEP96 12NOV96 . 11SEP96 . 12NOV96 . . . 11NOV96 11 1 . . . . . . . . . . 17203412SEP96 . . 12SEP96 . . . . . . . . . . . . . . . . . . 17203614OCT96 . . 14OCT96 . . . . . . . . . . . . . . . . . . 18009113FEB96 . . 14FEB96 . . . . . . . . . . . . . . . . . . 18132512MAR96 . . 13MAR96 . . . . . . . . . . . . . . . . . . 18134105MAR96 . . 06MAR96 . . . . . . . . . . . . . . . . . . 18142420FEB96 . . 20FEB96 . . . . . 29NOV96 18 2 . . . . . . . . 29NOV96 18 DECLINING CD4 COUNT. SIGNIFICENT MEASURABLE VIRAL LOAD. 18154620FEB96 . . 21FEB96 . . . . . 07JUL96 18 2 . . . . . . . . 07JUL96 18 PT. OBTAINED PROTEASE INHIBITOR THERAPY FROM P.M.D BECAUSE OF HIGH VIRAL LOAD RESULT FROM PERSONAL M.D. 18154727FEB96 . . 28FEB96 . . . . . . . . . . . . . . . . . . 18154823FEB96 . 28AUG96 26FEB96 . . . 28AUG96 . 28AUG96 15 1 . . . . . . . . . . 18154927FEB96 . . 28FEB96 . . . . . 07OCT96 16 2 . . . . . . . . 07OCT96 16 PT. WISHES TO USE OPEN-LABEL PROTEASE INMIBITOR. AFTER 6 MTS. ON STUDY HIS PHYSICIAN BELIEVES TCELL COUNT TO HAVE RESPONDED POORLY TO THERAPY 18155205APR96 . . 22APR96 . . . . . 10JUN96 16 2 . . . . . . 25SEP96 4 UNABLE TO CONTACT PT. AFTER REPEATED ATTEMPTS 10JUN96 16 PT. REQUIRES USE OF RIFAMPIN FOR MIA, AND CHRONIC STERIOD USE PREDRISON FOR ASTHAM. NO USE OF STUDY MED SINCE WEEK 8 VISIT. 18155316APR96 . . 17APR96 . . . . . . . . . . . . . . . . . . 18155927JUN96 . . 28JUN96 . . . . . . . . . . . . . . . . . . 18156515MAY96 . . 17MAY96 . . . . . . . . . . . . . . . . . . 18157209JUL96 . . 10JUL96 . . . . . . . . . . . . . . . . . . 18157513SEP96 . . . 6 . . . . . . . . . . . . . . . . . 18199318JUN96 . . 19JUN96 . . . . . . . . . . . . . . . . . . 18201705JUN96 . . 06JUN96 . . . . . . . . . . . . . . . . . . 18218005JUN96 . . 05JUN96 . . . . . . . . . . . . . . . . . . 18234003MAY96 . . 06MAY96 . . . . . . . . . . . . . . . . . . 18239527FEB96 . . 28FEB96 . . . . . . . . . . . . . . . . . . 18239616FEB96 . . 22FEB96 . . . . . . . . . . . . . . . . . . 18240204MAR96 . . 05MAR96 . . . . . . . . . . . . . . . . . . 18240518MAR96 . . 19MAR96 . . . . . . . . . . . . . . . . . . 18240726MAR96 . . 27MAR96 . . . . . . . . . . . . . . . . . . 18241108APR96 . . 09APR96 . . . . . 17NOV96 18 2 . . . . . . . . 17NOV96 18 PATIENT REQUESTED TO PERMANENTLY DISCONTINUE STUDY DRUGS AFTER RECEIVING HIGH HIV RNA RESULTS 18242012APR96 03SEP96 . 15APR96 . 04SEP96 . . . 03SEP96 13 1 . . . . . . . . . . 18243819JUL96 . . 22JUL96 . . . . . . . . . . . . . . . . . . 18244713SEP96 . . 16SEP96 . . . . . . . . . . . . . . . . . . 18247420DEC96 . . 26DEC96 . . . . . . . . . . . . . . . . . . 19027624APR96 . . 25APR96 . . . . . . . . . . . . . . . . . . 21006725MAR96 . 09JAN97 25MAR96 . . . 09JAN97 . 09JAN97 11 1 . . . . . . . . . . 21007427MAR96 . . 27MAR96 . . . . . . . . . . . . . . . . . . 21012213FEB96 . . 13FEB96 . . . . . . . . . . . . . . . . . . 21030712MAR96 . 19APR96 12MAR96 . . . 19APR96 . 18APR96 11 1 . . . 13MAY96 16 . . . 13MAY96 16 PT'S SPUTUM CULTURE FOR MTB WAS POSITIVE AND HE NEEDED TO USE RIFAMPIN. 21047607MAR96 . . 07MAR96 . . . . . . . . . . . . . . . . . . 21060312MAR96 . . 12MAR96 . . . . . . . . . . . . . . . . . . 21100415FEB96 . . 15FEB96 . . . . . . . . . . . . . . . . . . 21106524JUN96 . . 24JUN96 . . . . . . . . . . . . . . . . . . 21114422FEB96 . . 22FEB96 . . . . . . . . . . . . . . . . . . 21120620MAR96 . . 21MAR96 . . . . . . . . . . . . . . . . . . 21121719FEB96 . . 19FEB96 . . . . . . . . . . . . . . . . . . 21134915APR96 . . 15APR96 . . . . . . . . . . . . . . . . . . 21137009APR96 . . 09APR96 . . . . . . . . . . . . . . . . . . 21141308JUL96 . . 08JUL96 . . . . . . . . . . . . . . . . . . 21163428FEB96 . 23MAY96 28FEB96 . . . 23MAY96 . 22MAY96 11 1 . . . . . . . . . . 21163615APR96 . . 15APR96 . . . . . 19APR96 16 2 . . . . . . . . 19APR96 16 PT. DIAGNOSED W ITH TB. STARTED RIFAMPIN WHILE IN HOSPITAL 21171220FEB96 . . 20FEB96 . . . . . . . . . . . . . . . . . . 21185615FEB96 . . 15FEB96 . . . . . . . . . . . . . . . . . . 21186115FEB96 . . 15FEB96 . . . . . 15AUG96 19 2 . . . . . . . . 15AUG96 19 IN LIGHT OF RISING VIRAL LOAD RISK OF NOT BEING ON PROTEASE FELT TO BE UNTENABLE. 21186612MAR96 . . 12MAR96 . . . . . . . . . . . . . . . . . . 21188603JUN96 . . 03JUN96 . . . . . . . . . . . . . . . . . . 21188729FEB96 . . 29FEB96 . . . . . 20MAY96 19 2 . . . . . . . . 20MAY96 19 AT THE REQUEST OF THE PRIVATE MD AND THE INVESTIGATOR DUE TO GR 4 CR. FROM FOSCARNET AND GR. 4 LFT TOX. 21189421FEB96 . . 21FEB96 . . . . . . . . . . . . . . . . . . 21190017A