Experiment 1219573
Compounds isolated
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | IM |
| Organism | Empty organism |
| Citation | BYERS,VS: LEVIN,AS: WAITES,LA: STARRETT,BA: MAYER,RA: CLEGG,JA: PRICE,MR: ROBINS,RA: DELANEY,M: BALDWIN,RW:. (1990). A PHASE I/II STUDY OF TRICHOSANTHIN TREATMENT OF HIV DISEASE.. 4(12) |
| Amount utilized | |
| Compound isolated | |
| Disease | THE TITLE COMPOUND WAS USED TO TREAT 51 PATIENTS WITH ADVANCED HIV DISEASE IN A DOSE ESCALATION STUDY IN WHICH 3 INJECTIONS WERE ADMINISTERED OVER A 9-21 DAY PERIOD IN A DOSE RANGE OF 10-30 MCG/KG PER INJECTION. THE MAXIMUM TOLERATED DOSE WAS ESTIMATED TO BE 30 MCG/KG. REVERSIBLE BUT SEVERE FATIGUE AND MYALGIA WERE THE MAJOR DOSE-LIMITING SIDE-EFFECTS. MILD LEUCOCYTOSIS AND ELEVATIONS IN SERUM TRANSAMINASES WERE NOTED AND WERE REVERSIBLE. NON DOSE-RELATED REVERSIBLE MENTAL STATUS CHANGES WERE SEEN IN SIX PATIENTS AND WERE CONSIDERED TO BE ASSOCIATED WITH THE DRUG. THIS WAS USUALLY MANIFEST AS DEMENTIA, BUT PROGRESSED TO COMA IN TWO PATIENTS. THESE EFFECTS WERE REVERSED, BUT THE SEQUELAE RESULTED IN 1 DEATH. DECREASES IN SERUM P24 ANTIGEN LEVELS WERE NOTED 1 MONTH AFTER THE FIRST INJECTION IN 10/18 PATIENTS WHO ENTERED THE STUDY WITH ELEVATED LEVELS. 1 CONVERTED TO NEGATIVE. VALUES USUALLY REMAINED LOW TO THE END OF THE STUDY (2 MONTHS). IN THOSE PATIENTS WITH CD4+ CELL LEVELS MORE THAN 50 X 10(6) CELLS/L, SIGNIFICANT DECREASES IN SEDIMENTATION RATE AND INCREASES IN CD4+ CELL NUMBERS WERE ALSO NOTED. THESE CHANGES WERE FOUND AT ALL DOSE LEVELS BUT ONLY IN PATIENTS RECEIVING 3 INJECTIONS. THE FIRST FIVE PATIENTS WERE GIVEN THE DRUG BY THE IM ROUTE BUT THIS WAS STOPPED BECAUSE OF SEVERE PAIN, ERYTHEMA AND MUSCLE NECROSIS AT THE INJECTION SITE. ALL DEVELOPED RASHES 36 HRS AFTER INJECTION, PRIMARILY OF THE UPPER TRUNK. |
| Dose amount | 10.30 MCG |
| Number | 3 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | KG |
| Dose expression | DOSE |