|
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 Clinical research trials and Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 clinical trial. Participants typically obtain the most effective healthcare available for their Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2 condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2  Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
For Condition: HIV Infections
Status: Completed
Sponsor(s): Rockefeller University ,
Synopsis: To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
Details: Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity. In the first, dose-escalation phase of the study, PEG-IL-2 is injected into the skin of the back by either the intradermal (ID) or subcutaneous (SC) route, to establish an optimal dose (which when given ID results in local induration = or > 25 mm without significant toxicity). The ID and SC routes are compared for systemic effect and toxicity. In the second phase of the study, the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage, frequency, and route determined in the initial phase (probably 2-3 times per week) while local and systemic effects are monitored. These include measures of viral titer, peripheral blood mononuclear cell phenotype, CBC and CD4 counts, and in vitro cytotoxicity assays.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). - Necessary topical agents such as nystatin, clotrimazole, and acyclovir. - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Oral antibiotics for PCP prophylaxis if hematologically stable for = or > 30 days prior to study entry. - Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma. Patients must have: - HIV-1 seropositivity. - Asymptomatic. - No opportunistic infection for 8 weeks prior to study entry. - Been on azidothymidine (AZT) (= or > 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts. Prior Medication: Allowed: - Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens. - Fever = or > 101 F. within 10 days prior to study entry. - Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder. - Significant cardiac disease (New York Heart Association Stage III or IV). - Significant pulmonary disease (Forced Expiratory Volume < 75 percent. - Weight loss = or > 10 percent within last 3 months. Concurrent Medication: Excluded: - Systemic therapy for opportunistic infection (OI). Patients with the following are excluded: - Presence of antibody to interleukin-2 (IL-2). - Diseases or symptoms listed in Exclusion Co-Existing Conditions. Prior Medication: Excluded within 12 weeks prior to study entry: - Other immunomodulators. - Corticosteroids. - Other experimental therapy. - Anti-neoplastic chemotherapy. Active drug or alcohol abuse.
Total Enrollment:
Location and Contact Information:
Rockefeller Univ
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: 072A; COH-010-0790
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002017
Other Hiv Infections Studies:
1. A Study of Indinavir Sulfate Given Together with Stavudine to HIV-Positive Patients
2. HIV Prevention Preparedness Study in Russia, China, and India
3. Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
4. Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients with AIDS
5. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
|
|
|
|
|
|
|
|
