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A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 Clinical research trials and A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3. A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 clinical trial. Test subjects typically receive the most effective healthcare possible for their A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3  A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3
A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV. There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).
Details: There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2. Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Agree to practice abstinence or use effective birth control methods during the study. - Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3. - Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: - Have a history of progressive diseases. - Have a history of severe autoimmune/inflammatory disease. - Have Crohn's disease. - Are taking antiseizure medications or certain other medications. - Are receiving chemotherapy. - Are pregnant or breast-feeding. - Have ever received rIL-2.
Total Enrollment: 460
Location and Contact Information:
Overall Study Official:
DonaldAbrams, Study Chair,
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CPCRA 059;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000949
Other Hiv Infections Studies:
1. A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
2. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
3. A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
4. Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
5. A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
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A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients with CD4 Counts Greater than 300 Cells/mm3
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