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A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy Clinical research trials and A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy  A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Details: The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses. Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis. - Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex. - Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP. - Topical corticosteroids to areas separate from a skin test or IL-2 injection site. - Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes. - Erythropoietin and filgrastim. - Antiemetics. - Antibiotics as clinically indicated. - Elective standard immunizations at week 8 or later. Concurrent Treatment: Allowed: - Local radiation therapy. Prior Medication: Required: - Stable, approved antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry. Patients must have: - HIV seropositivity. - CD4 count 300 - 700 cells/mm3. - Stable antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry. - No history of AIDS-defining illness except for limited cutaneous Kaposi's sarcoma. - Normal EKG (isolated nonspecific ST and T wave changes permitted). NOTE: - This protocol is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy requiring systemic or local cytotoxic chemotherapy. - Untreated thyroid disease. - Asthma requiring intermittent or chronic inhalation or systemic therapy. - Any medical condition that precludes study entry. Concurrent Medication: Excluded: - Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics. - Systemic or local cytotoxic chemotherapy. - Interferons. - Interleukins other than study drug. - Pentoxifylline ( Trental ). - Acetylcysteine ( NAC ). - Sargramostim ( GM-CSF ). - Dinitrochlorobenzene ( DCNB ). - Thymosin alpha 1. - Thymopentin. - Inosiplex ( Isoprinosine ). - Polyribonucleoside ( Ampligen ). - Ditiocarb sodium ( Imuthiol ). - Therapeutic HIV vaccines. - Investigational antiretroviral agents such as lamivudine ( 3TC ) and tat and protease inhibitors. - Foscarnet. - Aspirin. - Immune globulin ( IVIG ). - Thalidomide. - Systemic corticosteroids (permitted for 21 days or less for PCP treatment only). Concurrent Treatment: Excluded: - Ongoing transfusion. Patients with the following prior conditions are excluded: - History of autoimmune disease, including inflammatory bowel disease and psoriasis (although autoimmune thyroid disease that is stable is allowed). - Clinically significant CNS disease or seizures that have been active within 1 year prior to study entry. Prior Medication: Excluded: - IL-2 within 3 months prior to study entry. - Any immunomodulatory therapy within 4 weeks prior to study entry. - Foscarnet within 4 weeks prior to study entry. - Acute therapy for an opportunistic infection within 14 days prior to study entry. Active alcohol or substance abuse that would compromise study compliance.
Total Enrollment: 104
Location and Contact Information:
Overall Study Official:
TepplerH, Study Chair,
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Additional Information:
Study ID Numbers: ACTG 248;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000820
Other Hiv Infections Studies:
1. A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
2. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3
3. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
4. Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
5. CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
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A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
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