drugset / Trial / NCT00650637
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.
Timeline
- Start
- 2003-01
- Primary completion
- 2003-08
- Completion
- 2003-08
Outcome
Outcome not reported
Stopped: “The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium carbonate | Other / unclassified | 500 mg | Oral |
| Background | Lamivudine | Other / unclassified | 150 mg | — |
| Background | Loperamide | Small molecule | 2 mg | Oral |
| Background | Nelfinavir | Other / unclassified | 1250 mg | — |
| Background | Stavudine | Other / unclassified | 40 mg | — |
| Background | Zidovudine | Small molecule | 300 mg | — |