| March 31, 2008 |
| October 7, 2008 |
| January 2003 |
| August 2003 (final data collection date for primary outcome measure) |
| Number of patients who experienced protocol-defined diarrhea in each treatment group during study [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00650637 on ClinicalTrials.gov Archive Site |
- Time to first occurrence of protocol-defined diarrhea [ Designated as safety issue: Yes ]
- The outcome of calcium carbonate plus loperamide in treating
subjects who experienced diarrhea [ Time Frame: Weeks 2, 4, 6, 8, and 12 ] [ Designated as safety issue: Yes ]
- Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide [ Time Frame: Weeks 2, 4, 6, 8, and 12 ] [ Designated as safety issue: Yes ]
- Safety evaluations including physical exam, weight and vital signs measurements [ Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12 ] [ Designated as safety issue: Yes ]
- Safety assessment of laboratory parameters [ Time Frame: Screening, baseline, Weeks 4, 8, and 12 ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea |
| A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea |
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. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Diarrhea |
- Drug: Calcium Carbonate
- Drug: nelfinavir
- Drug: lamivudine
- Drug: loperamide
- Other: Calcium carbonate not administered
- Drug: lamivudine + zidovudine
|
| |
| |
| |
| Terminated |
| 150 |
| August 2003 |
| August 2003 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Antiretroviral-naive patients with HIV-1 infection
- not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
- No antidiarrheal medication within 7 days prior to entry
Exclusion Criteria:
- Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
- Bloody stools within 7 days prior to study entry
- Any unstable or severe intercurrent medical condition, including active opportunistic infections
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00650637 |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| A4301004 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| October 2008 |
