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,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
| Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
| Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
| Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
| Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
| Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
| Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
| Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
| Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
| Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
| Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
| Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
| Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
| Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
| Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
| Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
| Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
| Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |