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A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 Clinical research trials and A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3. A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3 condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3  A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3
A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients. IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).
Details: IL-12 has a number of effects in vitro that could be relevant to HIV disease including promotion of TH1 cell development, enhancement of HIV-specific T cell responses in cells from subjects with AIDS, and, of particular relevance to MAC disease, increasing secretion of cytotoxic cytokines such as IFN-gamma from both T lymphocytes and NK cells. Part A (36 patients with less than 50 CD4+ cells/mm3): Patients are randomized within one of three sequential dose cohorts and receive either rhIL-12 or matching placebo by subcutaneous injection twice weekly for four weeks. Eligible patients will participate in only 1 of the 3 dosing cohorts. Dose escalation to a new cohort of patients in Part A will occur only if all 3 of the following occur: (1) At least 9 patients in the rhIL-12 arm have been enrolled in the current dose group and have either been on study drug for at least 4 weeks (temporary discontinuation is allowed) or have permanently discontinued study drug due to a primary toxicity endpoint. [(2) AS PER AMENDMENT 6/16/97: Fewer than 2 of the 12 patients receiving rhIL-12 at 30 or 100 ng/kg have had a primary toxicity endpoint.] (3) Adequate data from a Genetics Institute/Wyeth Ayerst-sponsored dose escalation trial have been obtained and analyzed to demonstrate the safety of the dose to be administered to the next cohort. Note: If 3 or more patients in the rhIL-12 arm of a given dose in Part A experience a primary toxicity endpoint, then accrual and further drug administration will be discontinued. [AS PER AMENDMENT 6/16/97: If a cohort has exactly two patients in the rhIL-12 arm that experience a primary toxicity endpoint, then the next cohort receives study drug at the same dose as the current cohort, but administered only once a week. If a cohort receiving study drug administered once a week has at least two subjects experience a primary toxicity endpoint, then further drug administration in Part A is stopped. Any cohort that receives study drug once a week is the last cohort in Part A; no further dose escalation is performed]. Part B (18 subjects with 300-500 CD4+ cells/mm3): Patients are randomized to receive either the maximum tolerated dose (determined in Part A) of rhIL-12 or matching placebo subcutaneously twice a week for 4 weeks. [AS PER AMENDMENT 01/29/99: Because of slow accrual for cohort 3 of Part A, concurrent enrollment will begin for Part B while cohort 3 of Part A is completed. There will be no further dose escalation in Part A. Part A will remain open to accrual until the final enrollee to Part B completes 4 weeks of study treatment. For Part B, 27 patients will be randomized with equal probability to one of two rhIL-12 doses or placebo. Semiweekly injections are given for 4 weeks.]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are 18-60 years old. - Have a CD4 count less than 50 cells/mm3 or between 300-500 cells/mm3 within 30 days of study entry. - Are expected to live at least 12 weeks. - Agree to practice abstinence or use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a history of cytomegalovirus (CMV) end-organ disease. - Have a history of invasive fungal disease, unless the condition has been stable for 2 months. - Have a history of severe allergic reactions to IL-2 or IL-12. - Have a history of heart problems, autoimmune or rheumatologic disease, gastrointestinal bleeding, or any condition that would keep you from completing the study. - Have MAC-related symptoms (fever, weight loss, frequent diarrhea) for at least 2 months prior to study entry. - Are enrolled in another experimental research treatment study. - Abuse alcohol or drugs. - Are pregnant or breast-feeding.
Total Enrollment: 65
Location and Contact Information:
Overall Study Official:
MarkJacobson, Study Chair,
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Willow Clinic
Menlo Park, California, 94025
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of Washington
Seattle, Washington, 98104
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Additional Information:
Study ID Numbers: ACTG 325;
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000857
Other Hiv Infections Studies:
1. Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
2. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
3. A Study of Lobucavir in Patients with AIDS
4. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
5. The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
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A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients with CD4 Cell Counts Less than 50 Cells/mm3 or 300-500 Cells/mm3
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