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The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Clinical research trials and The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3. The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3  The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 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 evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
Details: IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase II study helps develop the clinical experience needed to consider formation of a larger, more complete Phase III trial. Seventy-two HIV-infected patients (previously treated or naive) are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting toxicity (DLT) in at least 9 of 12 patients in Group 1, 12 additional patients are entered into Group 2 and treated as indicated. In the absence of DLT in 9 of 12 patients in Group 2, the final 12 patients are entered into Group 3. Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose. A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a CD4 cell count greater than or equal to 300 cells/mm3. - Have no AIDS-defining illnesses. - Are at least 18 years old. - Have been on antiretroviral therapy for at least 7 days prior to study entry. Exclusion Criteria Patients will not be eligible for this study if they: - Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study. - Have a history of the following: cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease. - Are pregnant or breast-feeding. - Have ever received IL-2.
Total Enrollment: 72
Location and Contact Information:
Thomas Street Clinic
Houston, Texas, 77009
United States
Houston Clinical Research Network
Houston, Texas, 77009
United States
OnCol Med Associates
Houston, Texas, 77027
United States
Additional Information:
Study ID Numbers: SQIL-2; IRP 021C,SQIL-2 Houston
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000825
Other Hiv Infections Studies:
1. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
2. A Study of L-735,524 in HIV-Positive Children and Adolescents
3. Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
4. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura
5. A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
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