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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002253 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diarrhea HIV Infections |
Drug: Octreotide |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Contacts and Locations
Hide Study Locations| United States, California | |
| UCSD Med Ctr | |
| San Diego, California, United States, 92103 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| San Mateo County Gen Hosp | |
| San Mateo, California, United States, 94403 | |
| USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Med Service | |
| Miami, Florida, United States, 33125 | |
| United States, Georgia | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maine | |
| Maine Med Ctr Med Clinics | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Boston City Hosp | |
| Boston, Massachusetts, United States, 02118 | |
| Douglas Plesko | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New York | |
| SUNY Stony Brook / Health Sciences Ctr | |
| Stony Brook, New York, United States, 117948121 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Miriam Hosp / Family Healthcare Ctr at SSTAR | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| United States, Wisconsin | |
| Univ of Wisconsin School of Medicine | |
| Madison, Wisconsin, United States, 53792 | |
More Information
| Study ID Numbers: | 102B, D204 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002253 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Octreotide Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Diarrhea Slow Virus Diseases Antineoplastic Agents, Hormonal Signs and Symptoms, Digestive Immune System Diseases Antineoplastic Agents Acquired Immunodeficiency Syndrome Gastrointestinal Agents Octreotide |
Infection Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
