Experiment 647102
Worktypes
Compounds isolated
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Empty organism |
| Citation | HOLODNIY,M: KOCH,J: MISTAL,M: SCHMIDT,JM: KHANDWALA,A: PENNINGTON,JE: PORTER,SB:. (1999). A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED SP-303 FOR THE SYMPTOMATIC TREATMENT OF DIARRHEA IN PATIENTS WITH AIDS.. 94(11) |
| Amount utilized | |
| Compound isolated | |
| Disease | THIS IS A MULTICENTER, PHASE II, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY. HIV-POSITIVE SUBJECTS WITH HISTORY OF A CD4 COUNT <200 ORA AN AIDS-DEFINING ILLNESS WERE ADMITTED TO AN INPATIENT STUDY UNIT AND SCREENED FOR DIARRHEA DEFINED AS AT LEAST THREE ABNORMAL (I.E., SOFT OR WATERY) STOOLS AND <200 G OF ABNORMAL STOOL WEIGHT OVER A 24-H PERIOD. SUBJECTS DISCONTINUED ALL ANTIDIARRHEAL AGENTS >24 H BEFORE ENROLLMENT. STOOL SAMPLES WERE STUDIED FOR ROUTINE PATHOGENS. SUBJECTS RECEIVED 500 MG P.O. OF SP-303 OR PLACEBO EVERY 6 H FOR 96 H (4 DAYS). STOOL FREQUENCY AND WEIGHTS WERE RECORDED. SUBJECTS WERE MONITORED FOR SYMPTOMS AND SIDE EFFECTS AND WERE SEEN 1 WEEK LATGER IN FOLLOW-UP. A TOTAL OF 26 SUBJECTS RECEIVED SP- 303, AND 25 RECEIVED PLACEBO. THERE WERE NO SIGNIFICANT DEMOGRAPHIC DIFFERENCES BETWEEN TREATMENT ARMS. A TOTAL OF 41 SUBJECTS(80%) WERE RECEIVING ANTIRETROVIRAL THERAPY AND 39 SUBJECTS(77%) WERE RECEIVING AT LEAST ONE PROTEASE INHIBITOR. STOOL STUDIES REVEALED NO PATHOGENS IN 48 OF 51 PATIENTS(94%). THERE WERE NO SERIOUS ADVERSE EVENTS OR LABORATORY ABNORMALITIES. THE SP-303 TREATMENT GROUP DEMONSTRATED A MEAN REDUCTION FROM BASELINE STOOL WEIGHT OF 451 G/24 H VERSUS 150 G/24 H WITH PLACEBO ON DAY 4 OF TREATMENT (P=0.14), AND A MEAN REDUCTION IN ABNORMAL STOOL FREQUENCY OF THREE ABNORMAL STOOLS IN 24 H VERSUS TWO IN 24 H IN THE PLACEBO GRUP (P=0.30). DAILY MEASURES ANALYSIS OVER 4 DAYS OF TREATMENT DEMONSTRATED THAT SP-303 SUBJECTS HAD A SIGNIFICANT REDUCTION IN STOOL WEIGHT (P=0.008) AND ABNORMAL STOOL FREQUENCY (P=0.04) WHEN COMPARED TO PLACEBO-TREATED SUBJECTS. |
| Dose amount | 2.0 GM |
| Number | 1 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | DAY |
| Dose expression | DOSE |
| Gender | GIVEN TO BOTH SEXES |