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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002252 |
Purpose
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
| Condition | Intervention |
|---|---|
|
Diarrhea HIV Infections |
Drug: Octreotide |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea |
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:
Prior Medication:
Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Present intravenous drug abuse.
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 | |
| Einstein Med School | |
| Bronx, New York, United States, 10461 | |
| 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: | 102A, D203 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002252 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 |