HIV Infections Clinical Trial
Official title:
A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
| NCT number | NCT00002253 |
| Other study ID # | 102B |
| Secondary ID | D204 |
| Status | Completed |
| Phase | N/A |
| First received | November 2, 1999 |
| Last updated | June 23, 2005 |
The primary objective of this study is to determine the relapse rate in patients with
AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled,
double-blind study of Sandostatin (Study #D203 - FDA 102A).
The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label
Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate
the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders"
from Study #D03 - FDA 102A.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria Patients must have the following: - Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study. - Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Infectious Disease Physicians Inc | Annandale | Virginia |
| United States | Emory Univ School of Medicine | Atlanta | Georgia |
| United States | Boston City Hosp | Boston | Massachusetts |
| United States | Douglas Plesko | Boston | Massachusetts |
| United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
| United States | Henry Ford Hosp | Detroit | Michigan |
| United States | Univ TX Galveston Med Branch | Galveston | Texas |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Univ of Missouri at Kansas City School of Medicine | Kansas City | Missouri |
| United States | USC School of Medicine | Los Angeles | California |
| United States | Univ of Wisconsin School of Medicine | Madison | Wisconsin |
| United States | Med Service | Miami | Florida |
| United States | Mount Sinai Med Ctr | New York | New York |
| United States | Buckley Braffman Stern Med Associates | Philadelphia | Pennsylvania |
| United States | Maine Med Ctr Med Clinics | Portland | Maine |
| United States | Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon |
| United States | Miriam Hosp / Family Healthcare Ctr at SSTAR | Providence | Rhode Island |
| United States | UCSD Med Ctr | San Diego | California |
| United States | Kaiser Permanente Med Ctr | San Francisco | California |
| United States | UCSF - San Francisco Gen Hosp | San Francisco | California |
| United States | San Mateo County Gen Hosp | San Mateo | California |
| United States | SUNY Stony Brook / Health Sciences Ctr | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Sandoz Inc. |
United States,
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