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Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection Clinical research trials and Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection. Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection  Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection
Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection
For Condition: HIV Infection
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will test whether the drug Interleukin-2 (IL-2), given together with antiretroviral drugs, can reduce the number of serious infections or prolong survival in people with HIV infection. IL-2 is a protein naturally produced by white blood cells called lymphocytes, which are important cells of the immune system. Lymphocytes from patients with HIV do not produce IL-2 normally and the total numbers of lymphocytes gradually decline with progressive disease. Administration of IL-2 has been shown capable of increasing the number of lymphocytes in treated patients above that usually reached through use of antiretroviral drugs alone. Patients with HIV infection 18 years and older who have no symptoms of significant HIV illness and no history of opportunistic infections may be eligible for this 6-year study. Candidates will be screened with a medical history and physical examination, including blood tests and urinalysis. Those enrolled in the study will be randomly assigned to one of two treatment groups, as follows: Group 1 will receive antiretroviral therapy alone. Patients in this group will be evaluated every 4 months with a physical examination and blood tests. Group 2 will receive antiretroviral therapy plus IL-2. In addition to antiretroviral drugs, patients will receive IL-2 injections under the skin twice a day, 5 days a week (one treatment cycle). The 5-day cycle will be repeated every 8 weeks for 3 cycles. Subsequent cycles will be scheduled based on the treatment response. Outpatients will be taught how to self-administer injections. Group 2 patients will be evaluated with a physical examination and blood tests every month for the first 6 months of treatment. Subsequent visits will be scheduled on an individual basis, but will be no less often than once every 4 months. Patients may need to be monitored daily during the 5 days of each injection cycle. Blood tests will also be done on day 5 of the first cycle and 1 month after the first cycle to evaluate drug side effects for possible dosage adjustments.
Details: The purpose of this study is to compare the effects of subcutaneous recombinant interleukin-2 (SC rIL-2) and no SC rIL-2 on disease progression and death over a 5-year follow-up period in patients with HIV-1 infection and absolute CD4+ cell counts of greater than or equal to 300/mm(3) who are taking combination antiretroviral therapy.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g. Western Blot); or any one of the following at any time: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or detectable proviral DNA. Absolute CD4(+) cell count of greater than or equal to 300/mm(3) within 45 days prior to randomization. (For patients who are status post-splenectomy, also a CD4(+) cell percentage greater than 20 percent). No evidence of active clinical disease for at least one year, in the judgement of the clinician, for any AIDS-defining illness or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal herpes zoster (greater than or equal to 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffei disease; visceral leishmaniasis; non-Hodgkin's lymphoma of any cell-type; Hodgkin's lymphoma; bartonellosis; microsporidiosis (greater than 1 month's duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease. Age greater than or equal to 18 years. Laboratory values (within 45 days prior to randomization): AST or ALT less than or equal to 5 times the upper limit of normal (ULN); Total or direct bilirubin less than or equal to 2 times ULN (Patients with hyperbilirubinemia due to Gilbert's syndrome or indinavir therapy may have a serum bilirubin up to 5 times ULN); Creatinine less than or equal to 2.0 mg/dL (177 micro mol/L); Platelet count greater than or equal to 50,000/mm(3); On or initiating combination antiretroviral therapy at the time of randomization. Antiretroviral therapy can include agents (approved and investigational) administered through routine care or through participation in clinical trials or expanded access programs. Signed informed consent form. EXCLUSION CRITERIA: Prior rIL-2 therapy. Concurrent malignancy requiring cytotoxic chemotherapy. Use of systemic corticosteroids, immunosuppressants, or cytotoxic agents within 45 days prior to study randomization. Any CNS abnormality that requires ongoing treatment with antiseizure medication. Current or historical autoimmune/inflammatory diseases including: Inflammatory bowel disease (Crohn's disease, ulcerative colitis); Psoriasis; Optic neuritis; or Any autoimmune/inflammatory diseases with potentially life-threatening complications. Pregnancy. (For women of childbearing potential, a negative pregnancy test, serum or urine, is required within 14 days prior to randomization). Breastfeeding
Total Enrollment: 120
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000071; 00-I-0071
Study Start Date: February 11, 2000
Record last reviewed: January 30, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004737
Other Hiv Infection Studies:
1. Phase II Protocol with Laboratory Correlates of 1-[(S)-3-hydroxy-2-(phosphomethoxy)propyl]cytosine dihydrate (Cidofovir) in Patients with Kaposi's Sarcoma (KS)
2. Use of Combined Antiretroviral Therapy to Determine Sites of Persistent HIV Infection
3. Long-Term Survival with HIV: Psychological and Behavioral Factors Associated with the Transition from Adolescence to Young Adulthood
4. The Effect of Milk Thistle on the Pharmacokinetics of Indinavir
5. Kidney Transplant for HIV-Infected Patients in Renal Failure
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection
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